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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03414294
Registration number
NCT03414294
Ethics application status
Date submitted
9/01/2018
Date registered
29/01/2018
Date last updated
28/01/2020
Titles & IDs
Public title
A Study to Evaluate the Safety of K-755 in Healthy Volunteers
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Scientific title
A Phase I Single-Center, Randomized, Double-Blind, Placebo-Controlled, Combined Single Ascending Dose, Multiple Ascending Dose, and Food Effect Study to Investigate the Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of K-755 in Healthy Adult Volunteers
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Secondary ID [1]
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K-755-1.01AU
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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:
Healthy
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - K-755 Part A (SAD)
Treatment: Drugs - Placebo Part A (SAD)
Treatment: Drugs - K-755 Part B (MAD)
Treatment: Drugs - Placebo Part B (MAD)
Treatment: Drugs - K-755 Part C (FE)
Treatment: Drugs - K-755 Part D (FE)
Treatment: Drugs - K-755 Part E (MAD)
Treatment: Drugs - Placebo Part E (MAD)
Experimental: K-755 Part A (SAD) -
Placebo Comparator: Placebo Part A (SAD) -
Experimental: K-755 Part B (MAD) -
Placebo Comparator: Placebo Part B (MAD) -
Experimental: K-755 Part C (FE) -
Experimental: K-755 Part D (FE) -
Experimental: K-755 Part E (MAD) -
Placebo Comparator: Placebo Part E (MAD) -
Treatment: Drugs: K-755 Part A (SAD)
Single ascending dose (SAD). There will be 7 cohorts in the Part A. Three quarters of subjects will receive K-755 tablet orally in a double-blind fashion.
Treatment: Drugs: Placebo Part A (SAD)
Single ascending dose (SAD). In Part A, one quarter of subjects will receive placebo tablet orally in a double-blind fashion.
Treatment: Drugs: K-755 Part B (MAD)
Multiple ascending dose (MAD). There will be 4 cohorts in the Part B. Three quarters of subjects will receive K-755 oral tablet in a double-blind fashion.
Treatment: Drugs: Placebo Part B (MAD)
Multiple ascending dose (MAD). In Part B, one quarter of subjects will receive placebo tablet orally in a double-blind fashion.
Treatment: Drugs: K-755 Part C (FE)
Food effect (FE). All subjects in Part C will receive K-755 oral tablet both under fed and fasted condition in a open-label, crossover fashion.
Treatment: Drugs: K-755 Part D (FE)
Food effect (FE). All subjects in Part D will receive K-755 oral tablet both under fed and fasted condition in a open-label, crossover fashion.
Treatment: Drugs: K-755 Part E (MAD)
Multiple ascending dose (MAD). There will be 2 cohorts in the Part E. Three quarters of subjects will receive K-755 oral tablet in a double-blind fashion.
Treatment: Drugs: Placebo Part E (MAD)
Multiple ascending dose (MAD). In the Part E. One quarter of subjects will receive placebo tablet orally in a double-blind fashion.
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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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Part A, B, C, D and E: Incidence and severity of Adverse Events
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Assessment method [1]
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A treatment-emergent adverse events (TEAE) will be summarized by treatment and overall, and summarized for each treatment by severity and relationship to study drug. All TEAEs leading to withdrawal, or SAEs, will be summarized.
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Timepoint [1]
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Up to 28 days after last administration
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Primary outcome [2]
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Part A, B, C, D and E: Number of subjects with clinical laboratory test abnormalities
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Assessment method [2]
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The clinical laboratory will include hematology (hematocrit, hemoglobin, mean cell hemoglobin, mean cell hemoglobin concentration, mean cell volume, platelet count, red blood cell count, white blood cell count), clinical chemistry (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, blood urea nitrogen, calcium, chloride, cholesterol, creatinine, creatine phosphokinase, direct bilirubin, estimated glomerular filtration rate, gamma glutamyl transferase, glucose. inorganic phosphate, iron, lactate dehydrogenase, phosphorus, potassium, sodium, total bilirubin, total CO2, total protein, triglyceride, urea, uric acid), and urinalysis (bilirubin, blood, color and appearance, glucose, ketones, leukocyte esterase, nitrite, pH, protein, specific gravity, urobilinogen, microscopic examination, electrolytes). Abnormality will be determined by the investigator.
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Timepoint [2]
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Up to 28 days after last administration
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Primary outcome [3]
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Part A, B, C, D and E: Number of subjects with vital signs abnormalities
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Assessment method [3]
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The vital sign will include blood pressure (mmHg), pulse rate (bpm), respiratory rate (breaths/min), and body temperature (degree Celsius). Abnormality will be determined by the investigator.
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Timepoint [3]
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Up to 28 days after last administration
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Primary outcome [4]
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Part A, B, C, D and E: Number of subjects with clinically significant change in body weight
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Assessment method [4]
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Change in body weight (kg) at baseline and post dose will be measured. Clinical significance will be determined by the investigator.
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Timepoint [4]
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Up to 28 days after last administration
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Primary outcome [5]
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Part A, B, C, D and E: Number of subjects with abnormal findings in physical examinations
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Assessment method [5]
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The physical examination will typically include general appearance, head and neck, eyes, ear, nose and throat, lymph nodes, thyroid, cardiovascular, respiratory, abdomen, nervous, skin, musculoskeletal, peripheral vascular and extremities and be performed at Investigator's discretion based on reported symptoms. Abnormality will be determined by the investigator.
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Timepoint [5]
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Up to 28 days after last administration
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Secondary outcome [1]
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Part A: AUC0-inf of K-755
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Assessment method [1]
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Area under the plasma concentration-time curve (AUC) from time zero extrapolated to infinity
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Timepoint [1]
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Up to 28 days after single administration
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Secondary outcome [2]
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Part A: AUC0-tlast of K-755
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Assessment method [2]
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AUC from time zero to the time of the last measurable concentration
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Timepoint [2]
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Up to 28 days after single administration
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Secondary outcome [3]
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Part A: Cmax of K-755
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Assessment method [3]
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Maximum plasma concentration
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Timepoint [3]
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Up to 28 days after single administration
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Secondary outcome [4]
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Part A: Tmax of K-755
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Assessment method [4]
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Time of the observed maximum plasma concentration
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Timepoint [4]
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Up to 28 days after single administration
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Secondary outcome [5]
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Part A: t1/2 of K-755
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Assessment method [5]
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Terminal plasma elimination half-life
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Timepoint [5]
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Up to 28 days after single administration
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Secondary outcome [6]
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Part B: AUC0-t of K-755
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Assessment method [6]
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AUC over the dosing interval
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Timepoint [6]
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Up to 28 days after repeated administration
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Secondary outcome [7]
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Part B: Cmax of K-755
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Assessment method [7]
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Maximum plasma concentration
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Timepoint [7]
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Up to 28 days after repeated administration
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Secondary outcome [8]
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Part B: Tmax of K-755
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Assessment method [8]
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Time of the observed maximum plasma concentration
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Timepoint [8]
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Up to 28 days after repeated administration
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Secondary outcome [9]
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Part B: t1/2 of K-755
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Assessment method [9]
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Terminal plasma elimination half-life
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Timepoint [9]
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Up to 28 days after repeated administration
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Secondary outcome [10]
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Part C: AUC0-inf of K-755
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Assessment method [10]
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Area under the plasma concentration-time curve (AUC) from time zero extrapolated to infinity
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Timepoint [10]
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Up to 14 days after single administration
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Secondary outcome [11]
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Part C: AUC0-tlast of K-755
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Assessment method [11]
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AUC from time zero to the time of the last measurable concentration
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Timepoint [11]
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Up to 14 days after single administration
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Secondary outcome [12]
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Part C: Cmax of K-755
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Assessment method [12]
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Maximum plasma concentration
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Timepoint [12]
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Up to 14 days after single administration
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Secondary outcome [13]
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Part C: Tmax of K-755
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Assessment method [13]
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Time of the observed maximum plasma concentration
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Timepoint [13]
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Up to 14 days after single administration
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Secondary outcome [14]
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Part C: t1/2 of K-755
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Assessment method [14]
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Terminal plasma elimination half-life
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Timepoint [14]
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Up to 14 days after single administration
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Secondary outcome [15]
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Part D: AUC0-inf of K-755
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Assessment method [15]
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Area under the plasma concentration-time curve (AUC) from time zero extrapolated to infinity
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Timepoint [15]
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Up to 14 days after single administration
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Secondary outcome [16]
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Part D: AUC0-tlast of K-755
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Assessment method [16]
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AUC from time zero to the time of the last measurable concentration
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Timepoint [16]
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Up to 14 days after single administration
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Secondary outcome [17]
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Part D: Cmax of K-755
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Assessment method [17]
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Maximum plasma concentration
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Timepoint [17]
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Up to 14 days after single administration
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Secondary outcome [18]
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Part D: Tmax of K-755
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Assessment method [18]
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Time of the observed maximum plasma concentration
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Timepoint [18]
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Up to 14 days after single administration
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Secondary outcome [19]
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Part D: t1/2 of K-755
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Assessment method [19]
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Terminal plasma elimination half-life
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Timepoint [19]
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Up to 14 days after single administration
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Secondary outcome [20]
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Part E: AUC0-t of K-755
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Assessment method [20]
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AUC over the dosing interval
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Timepoint [20]
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Up to 14 days after single administration
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Secondary outcome [21]
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Part E: Cmax of K-755
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Assessment method [21]
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Maximum plasma concentration
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Timepoint [21]
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Up to 14 days after single administration
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Secondary outcome [22]
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Part E: Tmax of K-755
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Assessment method [22]
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Time of the observed maximum plasma concentration
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Timepoint [22]
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Up to 14 days after single administration
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Secondary outcome [23]
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Part E: t1/2 of K-755
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Assessment method [23]
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Terminal plasma elimination half-life
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Timepoint [23]
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Up to 14 days after single administration
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Eligibility
Key inclusion criteria
1. Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
2. Males or females, of any race, between 18 and 45 years of age.
3. Body mass index (BMI) between 18.0 and 28.0 kg/m2.
4. Hematology, clinical chemistry, and urinalysis test results within the reference
ranges or showing no clinically relevant deviations, as judged by the Investigator.
5. No clinically significant abnormalities on the basis of medical history, physical
examination findings, and vital signs.
6. All females must have a negative serum pregnancy test.
7. Able and willing to comply with the protocol and study procedures.
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Minimum age
18
Years
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Maximum age
45
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1. Female subject who are pregnant or breastfeeding.
2. Subject with presence of active or recurring clinically significant cardiovascular,
pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic,
hematologic, gastrointestinal, or metabolic disease requiring medical treatment.
3. Subject with any surgical or medical condition that might significantly alter the
absorption, distribution, metabolism, or excretion of K-755.
4. Subject with presence of an active malignancy or within the past 5 years a malignancy
of any type, other than basal cell carcinoma of the skin.
5. Subject has a history of type 1 hypersensitivity to any medication and/or clinically
relevant food allergies.
6. Subject has a history of drug addiction.
7. Subject has a positive screen for drugs of abuse, cotinine or alcohol.
8. Subject has a history of regular alcohol consumption within 6 months of the study.
9. Subject has smoked tobacco within 6 months prior to Check-in, or has used non-inhaled
tobacco- or nicotine-containing products within 3 months prior to Check-in.
10. Subject has used prescription or over-the-counter medications, dietary/nutritional
supplements (except paracetamol or vitamin supplements)
11. Subject has used steroid medications (oral, inhaled, parenteral, or topical) within 30
days or 5 half-lives (whichever is longer) before study drug administration.
12. Subject has participated in an investigational drug study within 30 days or 5
half-lives (whichever is longer) before study drug administration.
13. Subject has a positive screen for hepatitis B surface antigen, hepatitis C virus
antibody, or human immunodeficiency virus types 1 and 2 antigens/antibodies.
14. Subject has had a clinically significant acute illness within 4 weeks or other illness
within 5 days before the first study drug administration.
15. Subject or a family member of the subject is a member of the professional or ancillary
personnel working at the investigative site involved in the study.
16. Not suitable for entry into the study in the opinion of the Investigator.
17. Receipt of blood products within 2 months prior to Check-in.
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Study design
Purpose of the study
Other
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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
Other
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Other design features
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Phase
Phase 1
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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
27/02/2018
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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
14/11/2019
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Sample size
Target
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Accrual to date
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Final
121
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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CMAX, Clinical Research Pty Ltd - Adelaide
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Kowa Company, Ltd.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a Phase 1 study designed to explore the safety, tolerability and pharmacokinetics of
K-755 following oral administration to healthy male and female volunteers.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03414294
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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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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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03414294
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