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

Concert Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: [14C]-CTP-543

Study type: Interventional

Funder types: Industry

Identifiers

NCT04092712

CP543.1004

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Investigational Product

Experimental group

Description:

\[14C\]-CTP-543

Treatment:

Drug: [14C]-CTP-543