Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers
- Registration Number
- NCT04092712
- Lead Sponsor
- Concert Pharmaceuticals
- Brief Summary
This study will assess the absorption, metabolism, excretion, mass balance, safety, and tolerability of a single oral administration of \[14C\]-CTP-543 in healthy male subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
- Healthy male subjects between the ages of 19 and 55 years, inclusive (healthy is determined by medical evaluation, including medical history, full physical examination, vital signs, electrocardiogram, and clinical laboratory tests)
- Body Mass Index of 18.0 to 32.0 kg/m2
- Continuous non smoker who has not used nicotine containing products for at least 3 months prior to dosing and throughout the study
- Known immunodeficiency disorder, including positive serology for human immunodeficiency virus (HIV) at screening
- Infection with hepatitis B or hepatitis C viruses
- History of irregular bowel movements
- History of herpes zoster
- A positive tuberculosis test at screening or history of incompletely treated or untreated tuberculosis
- History or presence of alcoholism or drug abuse within the past 2 years prior to dosing
- Participation in another clinical study within 30 days prior to dosing
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Investigational Product [14C]-CTP-543 \[14C\]-CTP-543
- Primary Outcome Measures
Name Time Method Mass balance: Calculation of percent of total radioactivity recovered in feces From time zero up to 96 hours post-dose following oral administration of [14C]-CTP-543 up to Day 15 CTP-543 PK: Cmax Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose Maximum plasma concentration
CTP-543 PK: AUClast Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration (Clast)
CTP-543 metabolite PK: AUC0-last Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration (Clast)
CTP-543 PK: CL/F Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes).
CTP-543 metabolite PK: t1/2 Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose Total radioactivity in whole blood Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose CTP-543 PK: Tmax Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose Time for Cmax
CTP-543 PK: AUCinf Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose Area under the plasma concentration time profile from time 0 to infinity
CTP-543 metabolite PK: AUCinf Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose Area under the plasma concentration time profile from time 0 to infinity
Total [14C]: urine Pre-dose up to 336 hours post-dose Total radioactivity excreted into the urine from time zero to the time of last measurable concentration following oral administration of \[14C\]-CTP-543
Total [14C]: feces Pre-dose up to 336 hours post-dose Total radioactivity excreted into the feces from time zero to the time of last measurable concentration following oral administration of \[14C\]-CTP-543
CTP-543 PK: t1/2 Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose CTP-543 PK: Vz/F Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose Apparent volume of distribution following oral administration
CTP-543 metabolite PK: Cmax Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose Maximum plasma concentration
CTP-543 metabolite PK: Tmax Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose Time for Cmax
Total radioactivity in plasma Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose Mass balance: Calculation of percent of total radioactivity recovered in urine From time zero up to 96 hours post-dose following oral administration of [14C]-CTP-543 up to Day 15
- Secondary Outcome Measures
Name Time Method Number of Participants With Clinically Significant Change From Baseline in Respiratory Rate Screening, Pre-dose, 2, 8, 48 hours post-dose Respiratory rate measured in breaths per minute
Number of Participants With Clinically Significant Change From Baseline in Serum Chemistry Screening, Check-in, 8, 24 hours postdose Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram - QT Interval Screening, Pre-dose, 48 hours post-dose Number of Participants With Clinically Significant Change From Baseline in Coagulation Screening, Check-in, 8, 24 hours postdose Number of Participants With Clinically Significant Changes to the Physical Examination Screening up to Day 15 Clinically significant changes to the physical examination
Number of Participants With Clinically Significant Change From Baseline in Urinalysis Screening, Check-in, 8, 24 hours postdose Number of Participants With Clinically Significant Change From Baseline in Heart Rate Screening, Pre-dose, 2, 8, 48 hours post-dose Heart rate measured in beats per minute (bpm)
Number of Participants With Clinically Significant Change From Baseline in Blood Pressure Screening, Pre-dose, 2, 8, 48 hours post-dose Blood pressure measured in millimeters of mercury (mmHg)
Number of Participants With Clinically Significant Change From Baseline in Temperature Screening, Pre-dose, 2, 8, 48 hours post-dose Temperature measured in Celsius (°C)
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram - P Wave Screening, Pre-dose, 48 hours post-dose Adverse events Screening up to Day 15 Number of adverse events, which are any untoward medical occurrence regardless of attribution to study drug in a participant who received study drug
Number of Participants With Clinically Significant Change From Baseline in Hematology Screening, Check-in, 8, 24 hours postdose Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram - QRS Complex Screening, Pre-dose, 48 hours post-dose
Trial Locations
- Locations (1)
Celerion
🇺🇸Lincoln, Nebraska, United States