A Trial to Study the Absorption, Metabolism, and Excretion of [14C]-Praliciguat in Healthy Male Volunteers
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/5/2019 |
| Start Date: | March 1, 2019 |
| End Date: | April 2019 |
| Contact: | Hanna Kwak |
| Email: | hkwak@cyclerion.com |
| Phone: | (857) 338-3304 |
A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Praliciguat ([14C]-IW-1973) Following a Single Oral Dose in Healthy Male Subjects
The primary objective is to characterize the pharmacokinetics (PK) of praliciguat and total
radioactivity and to assess the elimination of total radioactivity from a single oral dose of
[14C]-praliciguat.
radioactivity and to assess the elimination of total radioactivity from a single oral dose of
[14C]-praliciguat.
Inclusion Criteria:
- 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 Criteria:
- Any active or unstable clinically significant medical condition
- Use of any prescribed or non-prescribed medication
Additional inclusion/exclusion criteria may apply per protocol
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