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

Phase 1CompletedNCT04092712

Concert Pharmaceuticals6 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

NA

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

6

Conditions

Healthy Volunteers

Interventions

[14C]-CTP-543DRUG

Single dose of radiolabeled CTP-543 (approximately 75 μCi) administered as an oral solution

Eligibility

Sex: MALEMin age: 19 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Celerion

Lincoln, Nebraska, United States

Outcomes

Primary Outcomes

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

Maximum plasma concentration

Time frame: 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

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose

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

Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration (Clast)

Time frame: 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

Time frame: 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).

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose

Data from ClinicalTrials.gov

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Secondary Outcomes

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

Time frame: 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)

Time frame: 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)

Time frame: 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

Time frame: 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)

Time frame: Screening, Pre-dose, 2, 8, 48 hours post-dose

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

Clinically significant changes to the physical examination

Time frame: Screening up to Day 15

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

NCT04092712 - Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers | Crick | Crick