Status:
COMPLETED
A Trial to Study the Absorption, Metabolism, and Excretion of [14C]-Olinciguat in Healthy Male Volunteers
Lead Sponsor:
Cyclerion Therapeutics
Conditions:
Healthy Volunteers
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
The primary objective is to characterize the pharmacokinetics (PK) of olinciguat and total radioactivity and to assess the elimination of total radioactivity from a single oral dose of \[14C\]-olincig...
Detailed Description
OLI-103 is a Phase 1 open-label, nonrandomized, single-dose study in up to 8 subjects that will be conducted at a single center in the US. Safety assessments will be performed throughout the clinic pe...
Eligibility Criteria
Inclusion
- Males of any race, between 18 and 55 years of age, inclusive
- Body mass index between 18 and 32 kg/m2, inclusive
- Subject is in good health and has no clinically significant findings on physical examination
- Men must agree to use protocol-specified contraception and also to not donate sperm throughout the study and for at least 90 days after the final dose of study drug
Exclusion
- Any active or unstable clinically significant medical condition
- Use of any prescribed or non-prescribed medication
- Additional inclusion/exclusion criteria may apply per protocol
Key Trial Info
Start Date :
January 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2019
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03795519
Start Date
January 17 2019
End Date
February 27 2019
Last Update
April 3 2019
Active Locations (1)
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1
Covance Clinical Research Unit Inc.
Madison, Wisconsin, United States, 53704