Trials / Completed
CompletedNCT07305779
A Trial to Test the Effects of Other Drugs on SEP-380135 in Healthy Men and Women
A Phase 1, Open-label, Single-sequence Pharmacokinetic Trial to Assess the Effect of a Single Oral Dose of SEP-380135 on the Potential for Cytochrome P4502D6 Mediated Drug-drug Interactions in Healthy Adults
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to assess the effect of cytochrome P450 isoenzyme 2D6 (CYP2D6) inhibition by quinidine on the pharmacokinetic (PK) parameters of a single dose SEP-380135 in healthy adult participants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SEP-380135 | Oral capsules. |
| DRUG | Quinidine Gluconate | Oral extended-release (ER) tablets. |
Timeline
- Start date
- 2025-03-07
- Primary completion
- 2025-05-03
- Completion
- 2025-05-03
- First posted
- 2025-12-26
- Last updated
- 2026-01-15
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07305779. Inclusion in this directory is not an endorsement.