Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1, Open-label Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of Oral [14C]-CTP-543 in Healthy Adult Male Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: [14C]-CTP-543


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational Product<br>[14C]-CTP-543 | Drug: [14C]-CTP-543<br>* Single dose of radiolabeled CTP-543 (approximately 75 μCi) administered as an oral solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | Maximum plasma concentration | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose | 
| CTP-543 PK: Tmax | Time for Cmax | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose | 
| 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: AUClast | Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration (Clast) | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose | 
| CTP-543 PK: AUCinf | Area under the plasma concentration time profile from time 0 to infinity | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose | 
| CTP-543 PK: CL/F | 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). | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose | 
| CTP-543 PK: Vz/F | Apparent volume of distribution following oral administration | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose | 
| CTP-543 metabolite PK: Cmax | Maximum plasma concentration | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose | 
| CTP-543 metabolite PK: Tmax | Time for Cmax | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose | 
| 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 | 
| CTP-543 metabolite PK: AUC0-last | Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration (Clast) | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose | 
| CTP-543 metabolite PK: AUCinf | Area under the plasma concentration time profile from time 0 to infinity | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose | 
| Total [14C]: urine | Total radioactivity excreted into the urine from time zero to the time of last measurable concentration following oral administration of [14C]-CTP-543 | Pre-dose up to 336 hours post-dose | 
| Total [14C]: feces | Total radioactivity excreted into the feces from time zero to the time of last measurable concentration following oral administration of [14C]-CTP-543 | Pre-dose up to 336 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Number of adverse events, which are any untoward medical occurrence regardless of attribution to study drug in a participant who received study drug | Screening up to Day 15 | 
| Number of Participants With Clinically Significant Change From Baseline in Heart Rate | Heart rate measured in beats per minute (bpm) | Screening, Pre-dose, 2, 8, 48 hours post-dose | 
| Number of Participants With Clinically Significant Change From Baseline in Blood Pressure | Blood pressure measured in millimeters of mercury (mmHg) | Screening, Pre-dose, 2, 8, 48 hours post-dose | 
| Number of Participants With Clinically Significant Change From Baseline in Respiratory Rate | Respiratory rate measured in breaths per minute | Screening, Pre-dose, 2, 8, 48 hours post-dose | 
| Number of Participants With Clinically Significant Change From Baseline in Temperature | Temperature measured in Celsius (°C) | Screening, Pre-dose, 2, 8, 48 hours post-dose | 
| 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 Serum Chemistry |  | Screening, Check-in, 8, 24 hours postdose | 
| Number of Participants With Clinically Significant Change From Baseline in Coagulation |  | Screening, Check-in, 8, 24 hours postdose | 
| Number of Participants With Clinically Significant Change From Baseline in Urinalysis |  | Screening, Check-in, 8, 24 hours postdose | 
| Number of Participants With Clinically Significant Changes to the Physical Examination | Clinically significant changes to the physical examination | Screening up to Day 15 | 
| Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram - P Wave |  | Screening, Pre-dose, 48 hours post-dose | 
| Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram - QRS Complex |  | Screening, Pre-dose, 48 hours post-dose | 
| Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram - QT Interval |  | Screening, Pre-dose, 48 hours post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mass Balance, Radiolabeled, Pharmacokinetics