Trials / Completed
CompletedNCT01540500
Pharmacokinetics of Tasimelteon Alone and in Combination With CYP1A2 Inhibitor, Fluvoxamine
An Open-label, Single-sequence Study in Healthy Subjects to Evaluate the Single-dose Pharmacokinetics of Tasimelteon Alone and in Combination With a CYP1A2 Inhibitor, Fluvoxamine
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Vanda Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this research study is to evaluate whether administration of a CYP1A2 inhibitor affects the single-dose pharmacokinetics of tasimelteon and its metabolites. The safety and tolerability of tasimelteon will also be assessed throughout the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tasimelteon | 5.66 mg dose on Day 1 and Day 8 |
| DRUG | Fluvoxamine | 50 mg Dose on Days 2-8 |
Timeline
- Start date
- 2012-02-01
- Primary completion
- 2012-03-01
- Completion
- 2012-03-01
- First posted
- 2012-02-28
- Last updated
- 2014-02-17
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01540500. Inclusion in this directory is not an endorsement.