A Trial to Study the Absorption, Metabolism, and Excretion of [14C]-Olinciguat in Healthy Male Volunteers

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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 \[14C\]-olinciguat.

Key facts

Study ID

NCT03795519

Run by

Cyclerion Therapeutics

People needed

8

Starts

2019-01-17

Expected to finish

2019-02-27

Last updated by the study team

2019-04-03

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• Any active or unstable clinically significant medical condition
• Use of any prescribed or non-prescribed medication
• Additional inclusion/exclusion criteria may apply per protocol

Where it is running

• Covance Clinical Research Unit Inc. — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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