Status:
COMPLETED
Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers
Lead Sponsor:
Concert Pharmaceuticals
Collaborating Sponsors:
Celerion
Conditions:
Healthy Volunteers
Eligibility:
MALE
19-55 years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2019
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04092712
Start Date
September 5 2019
End Date
September 20 2019
Last Update
September 25 2019
Active Locations (1)
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1
Celerion
Lincoln, Nebraska, United States, 68502