Trials / Not Yet Recruiting
Not Yet RecruitingNCT07455084
A Study to Detect the Radioactivity of 14C-SEP-380135 in Urine and Feces in Healthy Male Adults
A Phase 1 Trial to Assess the Mass Balance and Pharmacokinetics of a Single Oral Administration of 14C-SEP-380135 in Healthy Male Adults
- Status
- Not Yet Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 8 (estimated)
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
- Sex
- Male
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The purpose of the present trial is to obtain information on the absorption, distribution, metabolism, excretion and pharmacokinetics (PK) of 14C-SEP-380135 and its metabolites following a single oral dose.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 14C-SEP-380135 | Oral Capsule |
Timeline
- Start date
- 2026-03-20
- Primary completion
- 2026-04-10
- Completion
- 2026-05-03
- First posted
- 2026-03-06
- Last updated
- 2026-03-06
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07455084. Inclusion in this directory is not an endorsement.