Trials / Completed
CompletedNCT03818295
A Trial to Study the Absorption, Metabolism, and Excretion of [14C]-Praliciguat in Healthy Male Volunteers
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- Cyclerion Therapeutics · Industry
- Sex
- Male
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | [14C]-praliciguat | 10 mg praliciguat containing approximately 500 μCi of \[14C\]-praliciguat |
Timeline
- Start date
- 2019-03-01
- Primary completion
- 2019-04-24
- Completion
- 2019-04-24
- First posted
- 2019-01-28
- Last updated
- 2019-06-19
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03818295. Inclusion in this directory is not an endorsement.