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

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT04092712

Run by

Concert Pharmaceuticals

People needed

6

Starts

2019-09-05

Expected to finish

2019-09-20

Last updated by the study team

2019-09-25

Who can join

Age: 19 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Celerion — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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