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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 11, 2019

Interventions

  • Drug: [14C]-CTP-543
    • Single dose of radiolabeled CTP-543 (approximately 75 μCi) administered as an oral solution

Arms, Groups and Cohorts

  • Experimental: Investigational Product
    • [14C]-CTP-543

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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: 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: 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: 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 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 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 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
  • 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 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
  • 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
  • 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 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
  • 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
  • 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

Secondary Measures

  • Adverse events
    • Time Frame: 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 Heart Rate
    • Time Frame: 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
    • Time Frame: 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 Respiratory Rate
    • Time Frame: 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 Temperature
    • Time Frame: Screening, Pre-dose, 2, 8, 48 hours post-dose
    • Temperature measured in Celsius (°C)
  • Number of Participants With Clinically Significant Change From Baseline in Hematology
    • Time Frame: Screening, Check-in, 8, 24 hours postdose
  • Number of Participants With Clinically Significant Change From Baseline in Serum Chemistry
    • Time Frame: Screening, Check-in, 8, 24 hours postdose
  • Number of Participants With Clinically Significant Change From Baseline in Coagulation
    • Time Frame: Screening, Check-in, 8, 24 hours postdose
  • Number of Participants With Clinically Significant Change From Baseline in Urinalysis
    • Time Frame: Screening, Check-in, 8, 24 hours postdose
  • Number of Participants With Clinically Significant Changes to the Physical Examination
    • Time Frame: Screening up to Day 15
    • Clinically significant changes to the physical examination
  • Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram – P Wave
    • Time Frame: Screening, Pre-dose, 48 hours post-dose
  • Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram – QRS Complex
    • Time Frame: Screening, Pre-dose, 48 hours post-dose
  • Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram – QT Interval
    • Time Frame: Screening, Pre-dose, 48 hours post-dose

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 19 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Concert Pharmaceuticals
  • Collaborator
    • Celerion
  • Provider of Information About this Clinical Study
    • Sponsor

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