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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04865393
Registration number
NCT04865393
Ethics application status
Date submitted
26/04/2021
Date registered
29/04/2021
Titles & IDs
Public title
Phase 1 Study of PK and Safety of SPR206 in Subjects With Various Degrees Of Renal Function
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Scientific title
A Phase 1, Open-label Study to Assess the Safety and Pharmacokinetics of SPR206 Following a Single IV Dose of SPR206 in Subjects With Varying Degrees of Renal Function
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Secondary ID [1]
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CDMRP-JW180095-B
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Secondary ID [2]
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SPR206-103
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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:
Renal Impairment
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Condition category
Condition code
Renal and Urogenital
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Kidney disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - SPR206
Experimental: SPR206 - SPR206 100mg single-dose IV infused over 1 hour
Treatment: Drugs: SPR206
SPR206 100 mg single-dose IV infused over 1 hour
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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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Time to the maximum plasma concentration (Tmax)
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Assessment method [1]
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Timepoint [1]
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36 hours after start of study drug IV infusion
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Primary outcome [2]
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Maximum plasma concentration (Cmax)
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Assessment method [2]
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Timepoint [2]
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36 hours after start of study drug IV infusion
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Primary outcome [3]
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Area under the concentration-time curve from time 0 to last measurable timepoint (AUC0-t)
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Assessment method [3]
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Timepoint [3]
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36 hours after start of study drug IV infusion
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Primary outcome [4]
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Area under the concentration-time curve from time 0 to infinity (AUC0-8)
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Assessment method [4]
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Timepoint [4]
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36 hours after start of study drug IV infusion
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Secondary outcome [1]
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Area under the concentration-time curve from time 0 to 8 hours (AUC0-8)
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Assessment method [1]
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Timepoint [1]
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8 hours after start of study drug IV infusion
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Secondary outcome [2]
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Terminal Elimination Rate Constant (kel)
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Assessment method [2]
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0
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Timepoint [2]
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36 hours after start of study drug IV infusion
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Secondary outcome [3]
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Terminal half-life (t1/2)
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Assessment method [3]
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Timepoint [3]
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36 hours after start of study drug IV infusion
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Secondary outcome [4]
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Total body clearance (CL)
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Assessment method [4]
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Timepoint [4]
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36 hours after start of study drug IV infusion
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Secondary outcome [5]
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Renal clearance (CLR)
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Assessment method [5]
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Timepoint [5]
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36 hours after start of study drug IV infusion
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Secondary outcome [6]
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Steady-state volume of distribution (Vss)
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Assessment method [6]
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Timepoint [6]
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36 hours after start of study drug IV infusion
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Secondary outcome [7]
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Amount of drug excreted in urine by interval (Aet) for Cohorts 1-4
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Assessment method [7]
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Timepoint [7]
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36 hours after start of study drug IV infusion
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Secondary outcome [8]
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Cumulative amount of drug excreted in urine at the end of each interval (Aeu) for Cohorts 1-4
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Assessment method [8]
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Timepoint [8]
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36 hours after start of study drug IV infusion
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Secondary outcome [9]
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Fraction of drug excreted in the urine expressed as a percentage (Ae%) for Cohorts 1-4
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Assessment method [9]
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Timepoint [9]
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36 hours after start of study drug IV infusion
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Secondary outcome [10]
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Fraction of dose excreted in the urine over a collection interval (Fe) for Cohorts 1-4
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Assessment method [10]
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Timepoint [10]
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36 hours after start of study drug IV infusion
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Secondary outcome [11]
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Cumulative fraction of dose excreted in the urine over (Feu) for Cohorts 1-4
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Assessment method [11]
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Timepoint [11]
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36 hours after start of study drug IV infusion
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Secondary outcome [12]
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Extraction ratio (ER) for subjects on dialysis (Cohort 5)
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Assessment method [12]
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Timepoint [12]
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Up to 1 day post dose - between start and end of hemodialysis
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Secondary outcome [13]
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Estimated hemodialysis clearance (CLHD) for subjects on dialysis (Cohort 5)
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Assessment method [13]
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Timepoint [13]
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Up to 1 day post dose - between start and end of hemodialysis
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Secondary outcome [14]
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Amount of the dose removed by hemodialysis (XHD) for subjects on dialysis (Cohort 5)
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Assessment method [14]
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Timepoint [14]
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Up to 1 day post dose - between start and end of hemodialysis
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Secondary outcome [15]
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Incidence of Treatment-Emergent Adverse Events
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Assessment method [15]
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To assess the incidents of treatment-emergent adverse events following SPR206 intravenous dose administration. AEs will be classified by System Organ Class (SOC) and Preferred Term (PT). Incidence, frequency, severity and duration will be presented.
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Timepoint [15]
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14 days post start of last study drug IV infusion
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Secondary outcome [16]
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Incidence of abnormal vital sign assessments - blood pressure
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Assessment method [16]
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To assess the incidents of abnormal systolic and diastolic blood pressure assessments following SPR206 intravenous dose administration. Values and changes from baseline at each scheduled time-point will be summarized using descriptive statistics (n, mean, SD, median, minimum, and maximum). Significant changes from baseline will be presented.
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Timepoint [16]
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14 days post study drug IV infusion
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Secondary outcome [17]
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Incidence of abnormal vital sign assessments - body temperature
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Assessment method [17]
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To assess the incidents of abnormal body temperature assessments following SPR206 intravenous dose administration. Values and changes from baseline at each scheduled time-point will be summarized using descriptive statistics (n, mean, SD, median, minimum, and maximum). Significant changes from baseline will be presented.
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Timepoint [17]
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14 days post study drug IV infusion
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Secondary outcome [18]
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Incidence of abnormal physical exam assessments
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Assessment method [18]
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To assess the incidents of abnormal body system assessments following SPR206 intravenous dose administration. Changes from baseline in physical examination findings will be classified as Normal, Abnormal NCS, and Abnormal CS. Frequency counts will be presented.
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Timepoint [18]
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14 days post study drug IV infusion
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Secondary outcome [19]
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Incidence of abnormal ECG assessments - heart rate
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Assessment method [19]
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To assess the incidents of abnormal heart rate assessment following SPR206 intravenous dose administration. Cardiac (12-Lead ECG) for heart rate will be classified as normal, abnormality that is NCS, and CS abnormality. Frequency counts by dose group and timepoint of collection will be presented.
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Timepoint [19]
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14 days post study drug IV infusion
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Secondary outcome [20]
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Incidence of abnormal ECG assessments - PR, RR, QRS, QT and QTcF interval
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Assessment method [20]
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To assess the incidents of abnormal PR interval, RR interval, QRS interval, QT interval and QTcF interval assessments following SPR206 intravenous dose administration. Cardiac (12-Lead ECG) results will be classified as normal, abnormality that is NCS, and CS abnormality. Frequency counts by dose group and timepoint of collection will be presented.
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Timepoint [20]
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14 days post study drug IV infusion
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Secondary outcome [21]
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Incidence of abnormal safety laboratory assessments
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Assessment method [21]
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To assess the incidents of abnormal hematology, serum chemistry, coagulation and urinalysis assessments following SPR206 intravenous dose administration. Values and changes from baseline at each scheduled time-point will be summarized using descriptive statistics (n, mean, SD, median, minimum, and maximum). Frequency counts of significant changes from baseline will be presented.
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Timepoint [21]
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14 days post study drug IV infusion
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Eligibility
Key inclusion criteria
Key
* BMI = 18.5 and = 39.9 (kg/m2) and weight between 50.0 and 130.0 kg (inclusive)
* Medically healthy without clinically significant abnormalities (Healthy Volunteers) or medically stable without clinically significant acute or chronic illness (Subjects with varying degrees of Renal Disease)
* Normal renal function with eGFR =90 mL/min/1.73m2 (Cohort 1), or renal insufficiency with eGFR 60 to <90 mL/min/1.73m2 (Cohort 2), 30 to <60 mL/min/1.73m2 (Cohort 3), or <30 mL/min/1.73m2 (Cohort 4), calculated using Modification of Diet in Renal Disease (MDRD). Subjects with ESRD must be receiving hemodialysis at least 3 times per week for at least 3 months at Screening (Cohort 5 only)
* Non-smoker for at least 1 month prior to screening for the study
* Ability and willingness to abstain from alcohol, caffeine, xanthine-containing beverages or food
* Other inclusion criteria per protocol
Key
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Minimum age
18
Years
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Maximum age
No limit
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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
* Any clinically significant medical history or abnormal findings upon physical examination, or clinical laboratory tests, not specifically excluded in other criteria below that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject
* Electrocardiogram (ECG) with QTcF interval duration equal or greater than 500 msec
* Hemoglobin (HB), hematocrit (HCT), white blood cell count (WBC), or platelet count less than the lower limit of normal range of the reference laboratory (Cohort 1). HB <8.5 gm/dL, WBC =3,000 cells/µL or platelet count =100,000 cells/µL (Cohorts 2-5)
* Results of biochemistry tests for alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin greater than 1.5 X the upper limit of normal (ULN) for the reference laboratory
* Recent history (within 6 months) of known or suspected Clostridium difficile infection
* History of chronic liver disease, cirrhosis, or biliary disease
* History of seizure disorder except childhood history of febrile seizures
* Positive urine drug/alcohol testing
* Positive testing for human immunodeficiency virus1/2 (HIV 1/2), hepatitis B surface antigen (HBsAg) or hepatitis C (HCV) antibodies
* History of substance abuse or alcohol abuse
* Known history of clinically significant hypersensitivity reaction or anaphylaxis to any medication
* Other exclusion criteria per protocol
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Study design
Purpose of the study
Other
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Allocation to intervention
NA
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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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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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
8/06/2021
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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
6/12/2021
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Sample size
Target
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Accrual to date
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Final
37
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Country [2]
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New Zealand
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State/province [2]
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Christchurch
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Spero Therapeutics
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Address
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Country
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Other collaborator category [1]
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Government body
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Name [1]
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United States Department of Defense
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
Evaluation of the pharmacokinetics (PK) of SPR206 in subjects with normal renal function, subjects with various degrees of renal insufficiency, and subjects with end-stage renal disease (ESRD) receiving hemodialysis (HD) therapy.
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Trial website
https://clinicaltrials.gov/study/NCT04865393
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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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David Melnick, MD
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Address
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Spero Therapeutics Inc
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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
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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 not provided in
https://clinicaltrials.gov/study/NCT04865393