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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- CTP-543 metabolite PK: Tmax
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 55 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Investigational Product
[14C]-CTP-543
Intervention: [14C]-CTP-543 (Drug)
Outcomes
Primary Outcomes
CTP-543 metabolite PK: Tmax
Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
Time for Cmax
Mass balance: Calculation of percent of total radioactivity recovered in feces
Time Frame: From time zero up to 96 hours post-dose following oral administration of [14C]-CTP-543 up to Day 15
CTP-543 PK: Cmax
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
Total radioactivity in whole blood
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 metabolite PK: Cmax
Time Frame: 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: t1/2
Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
CTP-543 PK: Vz/F
Time Frame: 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
Total radioactivity in plasma
Time Frame: 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
Time Frame: From time zero up to 96 hours post-dose following oral administration of [14C]-CTP-543 up to Day 15
Secondary Outcomes
- Number of Participants With Clinically Significant Change From Baseline in Respiratory Rate(Screening, Pre-dose, 2, 8, 48 hours post-dose)
- 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)
- 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)
- Number of Participants With Clinically Significant Change From Baseline in Blood Pressure(Screening, Pre-dose, 2, 8, 48 hours post-dose)
- Number of Participants With Clinically Significant Change From Baseline in Temperature(Screening, Pre-dose, 2, 8, 48 hours post-dose)
- 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 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)