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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-05

Study Completion Date

2019-09-20

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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Investigational Product

\[14C\]-CTP-543

Group Type EXPERIMENTAL

[14C]-CTP-543

Intervention Type DRUG

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

Interventions

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[14C]-CTP-543

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

Intervention Type DRUG

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

Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes