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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02469298
Registration number
NCT02469298
Ethics application status
Date submitted
23/04/2015
Date registered
11/06/2015
Titles & IDs
Public title
Safety, Tolerability and Clinical Effect of Danirixin in Adults With Influenza
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Scientific title
A Randomized, Double-blind, Placebo Controlled Study to Evaluate the Safety, Tolerability and Clinical Effect of Oral Danirixin (GSK1325756) in the Treatment of Healthy Adults With Acute, Uncomplicated Influenza (201682)
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Secondary ID [1]
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201682
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Virus Diseases
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - GSK1325756 (Danirixin)
Treatment: Drugs - Placebo To Match GSK1325756
Treatment: Drugs - Oseltamivir Phosphate
Treatment: Drugs - Placebo To Match Oseltamivir Phosphate
Experimental: Danirixin + Oseltamivir matching placebo - Subjects will receive 75 mg oral Danirixin twice daily with Oseltamivir matching placebo twice daily for a total of ten doses over five days
Placebo comparator: Danirixin matching placebo + Oseltamivir matching placebo - Subjects will receive Danirixin matching placebo twice daily with Oseltamivir matching placebo twice daily for a total of ten doses over five days
Experimental: Danirixin + Oseltamivir - Subjects will receive 75 mg oral Danirixin twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days
Active comparator: Danirixin matching placebo + Oseltamivir - Subjects will receive Danirixin matching placebo twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days
Treatment: Drugs: GSK1325756 (Danirixin)
It will be supplied as capsule shaped white film coated tablet containing 75 mg GSK1325756 for oral use
Treatment: Drugs: Placebo To Match GSK1325756
It will be supplied as capsule shaped white film coated placebo tablet for oral use
Treatment: Drugs: Oseltamivir Phosphate
It will be supplied as size 0 Swedish Orange capsule containing 75 mg Oseltamivir phosphate and overfill of pre-gelatinized starch for oral use
Treatment: Drugs: Placebo To Match Oseltamivir Phosphate
It will be supplied as size 0 Swedish Orange capsule containing pre-gelatinized starch and magnesium stearate for oral use
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
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Assessment method [1]
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AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.
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Timepoint [1]
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Up to Day 28/withdrawal
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Primary outcome [2]
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Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count
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Assessment method [2]
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Hematology parameters included Basophils, Eosinophils, Lymphocytes, Monocytes, Total neutrophils (Total ANC), Platelet count and WBC count. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
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Timepoint [2]
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Baseline (Day 1) and up to Day 28/withdrawal
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Primary outcome [3]
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Change From Baseline in Hematology Parameters- Hemoglobin
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Assessment method [3]
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Hematology parameters included Hemoglobin. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
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Timepoint [3]
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Baseline (Day 1) and up to Day 28/withdrawal
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Primary outcome [4]
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Change From Baseline in Hematology Parameters- Hematocrit
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Assessment method [4]
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Hematology parameters included Hematocrit. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
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Timepoint [4]
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Baseline (Day 1) and up to Day 28/withdrawal
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Primary outcome [5]
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Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH)
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Assessment method [5]
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Hematology parameters included Mean corpuscle hemoglobin (MCH). Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
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Timepoint [5]
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Baseline (Day 1) and up to Day 28/withdrawal
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Primary outcome [6]
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Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV)
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Assessment method [6]
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Hematology parameters included Mean corpuscle volume (MCV). Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
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Timepoint [6]
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Baseline (Day 1) and up to Day 28/withdrawal
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Primary outcome [7]
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Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count
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Assessment method [7]
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Hematology parameters included RBC count and Reticulocytes count. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
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Timepoint [7]
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Baseline (Day 1) and up to Day 28/withdrawal
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Primary outcome [8]
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Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein
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Assessment method [8]
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Clinical chemistry parameters included Albumin and Total protein. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
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Timepoint [8]
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Baseline (Day 1) and up to Day 28/withdrawal
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Primary outcome [9]
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Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT)
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Assessment method [9]
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Clinical chemistry parameters included Alkaline phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase and Gamma Glutamyl Transferase. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
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Timepoint [9]
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Baseline (Day 1) and up to Day 28/withdrawal
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Primary outcome [10]
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Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid
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Assessment method [10]
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Clinical chemistry parameters included Direct Bilirubin, Total Bilirubin, Creatinine and Uric acid. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
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Timepoint [10]
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Baseline (Day 1) and up to Day 28/withdrawal
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Primary outcome [11]
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Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN)
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Assessment method [11]
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Clinical chemistry parameters included Calcium, CO2 content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/(BUN). Blood samples were collected on Day 1, Day 3, Day 5 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
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Timepoint [11]
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Baseline (Day 1) and up to Day 28/withdrawal
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Primary outcome [12]
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Change From Baseline in Urinalysis Parameters- Urine pH
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Assessment method [12]
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Urinalysis parameters included urine pH. pH is calculated on a scale of 0 to 14, such that, the lower the number, more acidic the urine and higher the number, more alkaline the urine with 7 being neutral. Urinalysis was done on Day 1, Day 5 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
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Timepoint [12]
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Baseline (Day 1), Day 5 and Day 28/withdrawal
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Primary outcome [13]
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Change From Baseline in Urinalysis Parameters- Urine Specific Gravity
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Assessment method [13]
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Urinalysis parameter included Urine specific gravity and was measured on Day 1, Day 5 and Day 28. Urinary specific gravity is a measure of the concentration of solutes in the urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
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Timepoint [13]
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Baseline (Day 1), Day 5 and Day 28/withdrawal
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Primary outcome [14]
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Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Occult Blood (Dipstick)
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Assessment method [14]
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The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine occult blood can be read as negative, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Assessments recorded on Day 1 were considered as Baseline.
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Timepoint [14]
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Up to Day 28/withdrawal
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Primary outcome [15]
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Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Glucose (Dipstick)
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Assessment method [15]
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The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine glucose can be read as negative, Trace, 1+ or 1/4 gram per deciliter (G/dL), 2+ OR 1/2 G/dL, 3+ or 1 G/dL and 4+ indicating proportional concentrations in the urine sample. Assessments recorded on Day 1 were considered as Baseline.
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Timepoint [15]
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Up to Day 28/withdrawal
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Primary outcome [16]
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Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Protein (Dipstick)
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Assessment method [16]
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The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine protein can be read as negative, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Assessments recorded on Day 1 were considered as Baseline.
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Timepoint [16]
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Up to Day 28/withdrawal
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Primary outcome [17]
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Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
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Assessment method [17]
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Vital signs were measured in semi-supine position after 5 minutes rest and included systolic and diastolic blood pressure. Three readings of blood pressure were taken; the first reading was rejected and the second and third readings were averaged to give the measurement to be recorded. Vital signs were obtained on Baseline (Day 1), Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
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Timepoint [17]
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Baseline (Day 1) and up to Day 28/withdrawal
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Primary outcome [18]
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Change From Baseline in Vital Signs- Heart Rate (HR)
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Assessment method [18]
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Vital signs were measured in semi-supine position after 5 minutes rest and included HR. Three readings of pulse rate were taken; the first reading was rejected and the second and third readings were averaged to give the measurement to be recorded. Vital signs were obtained on Day 1, Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
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Timepoint [18]
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Baseline (Day 1) and up to Day 28/withdrawal
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Primary outcome [19]
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Change From Baseline in Vital Signs- Respiration Rate (RR)
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Assessment method [19]
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Vital signs were measured in semi-supine position after 5 minutes rest and included RR. RR was obtained on Day 1, Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
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Timepoint [19]
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Baseline (Day 1) and up to Day 28/withdrawal
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Primary outcome [20]
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Change From Baseline in Vital Signs- Temperature
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Assessment method [20]
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Vital signs were measured in semi-supine position after 5 minutes rest and included temperature. Oral temperature was obtained on Day 1, Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
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Timepoint [20]
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Baseline (Day 1) and up to Day 28/withdrawal
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Primary outcome [21]
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Change From Baseline in Vital Signs- Percent Oxygen in Blood (POB)
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Assessment method [21]
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Vital signs were measured in semi-supine position after 5 minutes rest and included POB. POB was obtained on Baseline (Day 1), Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
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Timepoint [21]
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Baseline (Day 1) and up to Day 28/withdrawal
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Primary outcome [22]
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Change From Baseline in Electrocardiogram (ECG) Parameters
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Assessment method [22]
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12-lead ECGs were obtained on Day 1, Day 3 and Day28/withdrawal using an ECG machine that automatically calculates and measures RR, PR, QRS, QT, and Corrected QT Interval using Bazette's formula (QTcB) and Corrected QT Interval using Fridericia forumula (QTcF) intervals. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
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Timepoint [22]
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Baseline (Day 1) and up to Day 28/withdrawal
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Primary outcome [23]
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Number of Participants With Disease Related Events (DREs) of Interest
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Assessment method [23]
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Disease-related events of interest included Otitis media, Sinusitis, Bronchitis and Pneumonia and were captured separately from AEs and SAEs. DREs of interest were assessed and recorded by the site on all clinical visit days.
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Timepoint [23]
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Up to Day 28/withdrawal
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Primary outcome [24]
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Number of Participants With DRE of Interest-associated Antibiotic Use
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Assessment method [24]
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Use of antibiotics for DREs of interest was monitored. Roxithromycin was used for DRE sinusitis by one participant.
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Timepoint [24]
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Up to Day 28/withdrawal
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Secondary outcome [1]
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Time to Resolution of Fever Over Time Post Initiation of Treatment
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Assessment method [1]
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Time to resolution of fever was defined as the time when oral temperature was \<= 37.2 degree Celsius (\<=99.0 degree Fahrenheit) for at least 24 hours (with one hour window) without having taken any antipyretic medication for at least 4 hours. Temperature was taken orally and recorded in the eDiary, thrice daily from Day 1 to Day 5 (morning, noon, evening) and twice daily (morning, evening) from Day 6 to Day 14 by the participant using a digital thermometer provided by the study. For participants whose fever was not resolved by the Day 14 visit then after Day 14, participants continued to take oral temperature twice daily until temperature \<=37.2 degree Celsius or \<=99 degree Fahrenheit for 24 hours.
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Timepoint [1]
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Up to Day 28/withdrawal
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Secondary outcome [2]
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Number of Afebrile Participants Over Time Post Initiation of Treatment
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Assessment method [2]
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Afebrile participants were defined as participants with oral temperature \<=37.2 degree Celsius, \<=99.0 degree Fahrenheit over time post initiation of treatment. Temperature was taken orally and recorded in the eDiary, thrice daily from Day 1 to Day 5 (morning, noon, evening) and twice daily (morning, evening) from Day 6 to Day 14 by the participant using a digital thermometer provided by the study. For participants whose fever was not resolved by the Day 14 visit then after Day 14, participants continued to take oral temperature twice daily until temperature \<=37.2 degree Celsius or \<=99 degree Fahrenheit for 24 hours.
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Timepoint [2]
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Up to Day 28/withdrawal
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Secondary outcome [3]
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Number of Participants Who Used Relief Medication
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Assessment method [3]
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Use of study supplied relief medications (paracetamol and dextromethorphan for symptom relief were recorded in the eDiary and accordingly number of participants using these medications were recorded.
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Timepoint [3]
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0
Up to Day 28/withdrawal
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Secondary outcome [4]
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Number of Hospital Admissions Due to Influenza Infection
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Assessment method [4]
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Number of participants admitted in hospital due to influenza infection was recorded.
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Timepoint [4]
0
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Up to Day 28/withdrawal
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Secondary outcome [5]
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Change From Baseline in Influenza Viral Load as Measured by Quantitative Reverse Transcription-polymerase Chain Reaction (qRT-PCR) From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14
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Assessment method [5]
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Influenza viral load as measured by quantitative reverse transcription - polymerase chain reaction (qRT-PCR) from nasopharyngeal swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 was recorded. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
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Timepoint [5]
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Baseline (Day 1) and Day 3, Day 5, Day 8 and Day 14
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Secondary outcome [6]
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Number of Participants With no Detectable Influenza Viral RNA by qRT-PCR From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14
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Assessment method [6]
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Number of participants with no detectable influenza viral ribonucleic acid (RNA) by qRT-PCR from nasopharyngeal swabs on Baseline (Day1), Day 3, Day 5, Day 8 and Day 14 were recorded. Assessments recorded on Day 1 were considered as Baseline.
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Timepoint [6]
0
0
Up to Day 14
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Secondary outcome [7]
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Total Dose of Relief Medication
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Assessment method [7]
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Use of study supplied relief medications (paracetamol and dextromethorphan for symptom relief were recorded in the eDiary and accordingly number of participants using these medications were recorded. The total dose of these relief medications used by these participants are presented.
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Timepoint [7]
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0
Up to Day 28/withdrawal
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Secondary outcome [8]
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Change From Baseline in Influenza Viral Load as Measured by Quantitative Virus Culture From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14
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Assessment method [8]
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Influenza viral load as measured by quantitative virus culture from nasopharyngeal swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 was recorded. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
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Timepoint [8]
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Baseline (Day 1) and Day 3, Day 5, Day 8 and Day 14
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Secondary outcome [9]
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Number of Participants With no Detectable Influenza Viral RNA by Quantitative Virus Culture From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14
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Assessment method [9]
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Number of participants with no detectable influenza viral RNA by quantitative virus culture from nasopharyngeal swabs on Baseline (Day1), Day 3, Day 5, Day 8 and Day 14 were recorded. Assessments recorded on Day 1 were considered as Baseline.
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Timepoint [9]
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Up to Day 14
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Eligibility
Key inclusion criteria
* Between 18 and 64 years of age inclusive, at the time of signing the informed consent;
* Onset of influenza-like illness symptoms within 48 hours prior to study enrollment. Onset of symptoms is defined as the time when the subject's temperature was measured as elevated (>=38.0°C [>=100.4°F]) OR the time when the subject first experienced at least one symptom (cough, sore throat, nasal congestion, headache, feeling feverish, body aches and pains, or fatigue);
* Subjects have an oral temperature >=38.0°C (>=100.4°F) at screening visit or history of feeling feverish within the 24 hours prior to screening visit;
* At least one respiratory symptom (cough, sore throat, nasal congestion) and at least one systemic symptom (headache, body aches and pain, fatigue) due to influenza infection;
* A positive influenza rapid antigen test;
* Body weight >60 Kilogram (kg) for men and >45 kg for women; and Body Mass Index (BMI) between 19 to 35 kilogram per meters squared (kg/m^2), inclusive;
* Male or Female subjects could be eligible if :
Male subjects with female partners of child-bearing potential must comply with the following contraception requirements from the time of first dose of study medication until at least 36 hours (five half-lives) of study medication after the last dose of study medication:
Vasectomy with documentation of azoospermia; Male condom plus partner use of one of the following contraceptive options: Contraceptive subdermal implant; Intrauterine device or intrauterine system; Oral Contraceptive, either combined or progestogen alone; Injectable progestogen; Contraceptive vaginal ring ; Percutaneous contraceptive patches; This is an all-inclusive list of those methods that meet the following GlaxoSmithKline (GSK) definition of highly effective: having a failure rate of less than 1% per year when used consistently and correctly and, when applicable, in accordance with the product label. For non-product methods (e.g., male sterility), the investigator determines what is consistent and correct use. The GSK definition is based on the definition provided by the International Conference on Harmonisation (ICH). The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception;
* Female subject: is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin [hCG] test), not lactating, and at least one of the following conditions applies
Non-reproductive potential defined as:
Pre-menopausal females with one of the following: documented Tubal ligation; Documented Hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; Hysterectomy; Documented Bilateral oophorectomy; Postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone [FSH] and estradiol levels consistent with menopause). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study.
Reproductive potential agrees to follow one of the options listed below in the GSK Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) requirements from the time of screening, during dosing, and until at least 36 hrs after the last dose of study medication and completion of the follow-up visit.
GSK List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) meeting GSK criteria of highly effective: having a failure rate of less than 1% per year when used consistently and correctly and, when applicable, in accordance with the product label. This list does not apply to FRP with same sex partners, when this is their preferred and usual lifestyle or for subjects who are and will continue to be abstinent from penilevaginal intercourse on a long term and persistent basis.
Contraceptive subdermal implant; Intrauterine device or intrauterine system; Combined estrogen and progestogen oral contraceptive; Injectable progestogen; Contraceptive vaginal ring; Percutaneous contraceptive patches; Male partner sterilization with documentation of azoospermia prior to the female subject's entry into the study, and this male is the sole partner for that subject.
These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception.
- Subjects willing and able to give written informed consent to participate in the study and to adhere to the procedures stated in the protocol.
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Minimum age
18
Years
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Maximum age
64
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Subject defined as being at high risk of complications from influenza infection according to the World Health Organization (WHO) Guidelines for Pharmacological Management of Pandemic Influenza A (H1N1) and other Influenza Viruses: Pregnant women; Persons of any age with chronic pulmonary disease (e.g. Mild persistent, Moderate or severe asthma, Chronic Obstruction Pulmonary Disease [COPD], cystic fibrosis, bronchiectasis); Persons of any age with chronic cardiac disease (e.g. congestive cardiac failure);
* Persons with metabolic disorders (e.g. diabetes); Persons with chronic renal disease, chronic hepatic disease, certain neurological conditions (including neuromuscular, neurocognitive and seizure disorders, but not including autism spectrum disorders); Hemoglobinopathies, or immunosuppression, whether due to primary immunosuppressive conditions, such as Human Immunodeficiency Virus (HIV) infection, or secondary conditions, such as immunosuppressive medication or malignancy;
* Subjects in whom treatment with an influenza antiviral is considered essential;
* Severity of illness requiring or anticipated to require in-hospital care;
* Pulse Oximetry levels <92% (at rest on room air) at screening or requirement for supplemental oxygen;
* Any complication of respiratory tract infection, signs of severe or progressive disease, or worsening of any pre-existing medical condition at the time of enrollment, that, in the opinion of the investigator, would place the subject at an unreasonably increased risk of participation in this study;
* Suspicion or confirmation of bacterial infection (e.g. otitis media, sinusitis, bronchitis, focal pneumonia) or who are requiring oral or systemic antibiotics within one week before enrollment;
* Women who are pregnant as determined by a positive urine human chorionic gonadotrophin (hCG) test prior to dosing or women who are breastfeeding;
* Current or chronic documented history of liver disease (including Hepatitis A, B, or C), or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones); In this case "documented" refers to the outcome of the investigator's/designee's review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records). In questionable cases the subject cannot be enrolled;
* Corrected QT interval (QTc) >450 millisecond (msec) or QTc >480 msec in subjects with Bundle Branch Block.
* Subjects currently using or expected to use: oral or injectable Cytochrome P450 3A4 (CYP3A4) or Breast Cancer Resistance Protein (BCRP) substrates with a narrow therapeutic index, or oral or systemic glucocorticoids during the study period; Antacids can be used but should not be taken for at least 3 hours preceding and 2 hours after administration of study drug; proton pump inhibitors and histamine H2-receptor antagonists are prohibited from the screening visit until 12 hours after completion of the final dose of study treatment.
* Subjects who have taken an approved or investigational anti-influenza medication (e.g., oseltamivir, zanamivir, peramivir, laninamivir, amantadine, rimantidine, ribavirin) within the past 4 weeks before enrollment;
* Subjects who received the live attenuated influenza virus vaccine within the past 21 days;
* Subjects treated with systemic steroids or immunosuppressants within 2 weeks of study start.
* History of alcohol/drug abuse within 6 months of the study start;
* Consumption of >3 alcoholic units for males and females over the past 24 hours. One unit is equivalent to 8 grams of alcohol: a half-pint (~240 milliliter [mL]) of beer; 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
* History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
* Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period;
* The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer);
* Exposure to more than four investigational medicinal products within 12 months prior to the first dosing day.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
25/04/2016
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Sample size
Target
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Accrual to date
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Final
45
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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GSK Investigational Site - Baulkham Hills
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GSK Investigational Site - Brookvale
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GSK Investigational Site - Hinchinbrook
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GSK Investigational Site - Liverpool
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GSK Investigational Site - Browns Plains
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GSK Investigational Site - Everton Plaza
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GSK Investigational Site - Kedron
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GSK Investigational Site - Springfield
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GSK Investigational Site - Happy Valley
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Recruitment hospital [11]
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GSK Investigational Site - Berwick
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Recruitment hospital [19]
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GSK Investigational Site - Morley
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Recruitment hospital [20]
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GSK Investigational Site - Yokine
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Recruitment postcode(s) [1]
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2153 - Baulkham Hills
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Recruitment postcode(s) [2]
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2100 - Brookvale
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Recruitment postcode(s) [3]
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2168 - Hinchinbrook
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Recruitment postcode(s) [4]
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2170 - Liverpool
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Recruitment postcode(s) [5]
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4118 - Browns Plains
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Recruitment postcode(s) [6]
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4053 - Everton Plaza
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Recruitment postcode(s) [7]
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4031 - Kedron
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Recruitment postcode(s) [8]
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4300 - Springfield
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Recruitment postcode(s) [9]
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5045 - Glenelg East
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Recruitment postcode(s) [10]
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5159 - Happy Valley
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Recruitment postcode(s) [11]
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3806 - Berwick
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Recruitment postcode(s) [12]
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3975 - Lynbrook
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Recruitment postcode(s) [13]
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3174 - Noble Park
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Recruitment postcode(s) [14]
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3180 - Pakenham
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Recruitment postcode(s) [15]
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3029 - Tarneit
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Recruitment postcode(s) [16]
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6153 - Applecross
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Recruitment postcode(s) [17]
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6171 - Baldivis
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6010 - Claremont
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Recruitment postcode(s) [19]
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6062 - Morley
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Recruitment postcode(s) [20]
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6060 - Yokine
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Recruitment outside Australia
Country [1]
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United States of America
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Florida
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United States of America
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Idaho
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United States of America
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Oklahoma
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United States of America
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Oregon
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United States of America
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Wisconsin
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South Africa
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Eastern Cape
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South Africa
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Gauteng
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South Africa
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Mpumalanga
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South Africa
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Western Province
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South Africa
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Reiger Park
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
GlaxoSmithKline
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
Study 201682 is a Phase IIa, randomized, double blind, placebo-controlled four arm outpatient study evaluating the safety, tolerability and clinical effect of danirixin or danirixin + oseltamivir combination in comparison to placebo or oseltamivir twice daily for 5 days in otherwise healthy adults with laboratory confirmed influenza infection. Danirixin is a selective and reversible C-X-C Chemokine Receptor 2 (CXCR2) antagonist that inhibits neutrophil transmigration and activation to areas of inflammation. The study endpoints are intended to test the hypothesis that inhibition of neutrophil activation by approximately 50-60% (as previously measured by cluster of differentiation \[CD11b\] expression in response to chemokine \[C-X-C motif\] ligand 1 \[CXCL1\] stimulation ex vivo in human studies) will not impact safety parameters or worsen clinical manifestations of disease, disease-related events of interest, or viral load, and may possibly improve these parameters when administered within 48 hours of symptom onset. The aim of this exploratory study is to obtain data on the safety, tolerability and clinical effect of GSK1325756 (danirixin \[DNX\]) alone or in combination with oseltamivir (OSV) in otherwise healthy adults with acute, uncomplicated influenza prior to future evaluation in hospitalized patients with complicated influenza. The primary objective is to assess safety and tolerability of DNX with and without a neuraminidase inhibitor through the evaluation of AEs, SAEs, clinical laboratory tests, vital signs, and electrocardiogram (ECG) parameters. Safety assessments will also include an assessment of disease related events (DREs) of interest and associated antibiotic use. The Influenza Intensity and Impact Questionnaire (FluiiQ™) will be used in the study to document patient reported outcomes (PROs). The screening visit in Australia will be composed of a pre-screen for influenza infection with an influenza rapid antigen test followed by a screen for the remaining eligibility criteria for those subjects with a positive result on the influenza rapid antigen test. FluiiQ is trademark owned by Measured Solutions for Health Private Limited.
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Trial website
https://clinicaltrials.gov/study/NCT02469298
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Trial related presentations / publications
Roberts G, Chen S, Yates P, Madan A, Walker J, Washburn ML, Peat AJ, Soucie G, Kerwin E, Roy-Ghanta S. Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, and Clinical Effect of Danirixin in Adults With Acute, Uncomplicated Influenza. Open Forum Infect Dis. 2019 Apr 22;6(4):ofz072. doi: 10.1093/ofid/ofz072. eCollection 2019 Apr.
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Public notes
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Contacts
Principal investigator
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GSK Clinical Trials
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Address
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GlaxoSmithKline
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Fax
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Email
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Contact person for public queries
Name
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Address
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
IPD for this study will be made available via the Clinical Study Data Request site.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
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When will data be available (start and end dates)?
IPD is available via the Clinical Study Data Request site (click on the link provided below)
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Available to whom?
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.clinicalstudydatarequest.com/SearchAllPostings.aspx?searchparam=201682
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02469298