Clinical trial NCT04092712: Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Mass Balance
Radiolabeled
Pharmacokinetics
Lead sponsor: Concert Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Celerion
First posted: 2019-09-17
Enrollment: 6
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mass balance: Calculation of percent of total radioactivity recovered in urine
timeFrame: From time zero up to 96 hours post-dose following oral administration of [14C]-CTP-543 up to Day 15
measure: Mass balance: Calculation of percent of total radioactivity recovered in feces
timeFrame: From time zero up to 96 hours post-dose following oral administration of [14C]-CTP-543 up to Day 15
measure: CTP-543 PK: Cmax
timeFrame: Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
measure: CTP-543 PK: Tmax
timeFrame: Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
measure: CTP-543 PK: t1/2
timeFrame: Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
measure: CTP-543 PK: AUClast
timeFrame: Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
measure: CTP-543 PK: AUCinf
timeFrame: Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
measure: CTP-543 PK: CL/F
timeFrame: Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
measure: CTP-543 PK: Vz/F
timeFrame: Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
measure: CTP-543 metabolite PK: Cmax
timeFrame: Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
measure: CTP-543 metabolite PK: Tmax
timeFrame: Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
measure: CTP-543 metabolite PK: t1/2
timeFrame: Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
measure: CTP-543 metabolite PK: AUC0-last
timeFrame: Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
measure: CTP-543 metabolite PK: AUCinf
timeFrame: Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
measure: Total [14C]: urine
timeFrame: Pre-dose up to 336 hours post-dose
measure: Total [14C]: feces
timeFrame: Pre-dose up to 336 hours post-dose
measure: Total radioactivity in whole blood
timeFrame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose
measure: Total radioactivity in plasma
timeFrame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose
Secondary outcomes:
measure: Adverse events
timeFrame: Screening up to Day 15
measure: Number of Participants With Clinically Significant Change From Baseline in Heart Rate
timeFrame: Screening, Pre-dose, 2, 8, 48 hours post-dose
measure: Number of Participants With Clinically Significant Change From Baseline in Blood Pressure
timeFrame: Screening, Pre-dose, 2, 8, 48 hours post-dose
measure: Number of Participants With Clinically Significant Change From Baseline in Respiratory Rate
timeFrame: Screening, Pre-dose, 2, 8, 48 hours post-dose
measure: Number of Participants With Clinically Significant Change From Baseline in Temperature
timeFrame: Screening, Pre-dose, 2, 8, 48 hours post-dose
measure: Number of Participants With Clinically Significant Change From Baseline in Hematology
timeFrame: Screening, Check-in, 8, 24 hours postdose
measure: Number of Participants With Clinically Significant Change From Baseline in Serum Chemistry
timeFrame: Screening, Check-in, 8, 24 hours postdose
measure: Number of Participants With Clinically Significant Change From Baseline in Coagulation
timeFrame: Screening, Check-in, 8, 24 hours postdose
measure: Number of Participants With Clinically Significant Change From Baseline in Urinalysis
timeFrame: Screening, Check-in, 8, 24 hours postdose
measure: Number of Participants With Clinically Significant Changes to the Physical Examination
timeFrame: Screening up to Day 15
measure: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram - P Wave
timeFrame: Screening, Pre-dose, 48 hours post-dose
measure: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram - QRS Complex
timeFrame: Screening, Pre-dose, 48 hours post-dose
measure: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram - QT Interval
timeFrame: Screening, Pre-dose, 48 hours post-dose
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion
state: Nebraska
Study officials:
References: