Trials / Completed
CompletedNCT02621385
Study to Assess the Effect of Multiple Doses of Tradipitant on CYP3A4 Using Midazolam as a Substrate in Healthy Subjects
An Open-label, Single-sequence Study to Assess the Effect of Multiple Doses of Tradipitant on Cytochrome P450 3A4 Using Midazolam as a Substrate in Healthy Subjects.
- 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
This study is designed to evaluate the potential effect of administration of tradipitant on CYP3A4 using midazolam pharmacokinetics as markers. The study will also further characterize the pharmacokinetics of tradipitant.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | tradipitant | test agent |
| DRUG | Midazolam | substrate for drug-drug interaction assessment |
Timeline
- Start date
- 2015-11-01
- Primary completion
- 2016-02-01
- First posted
- 2015-12-03
- Last updated
- 2016-04-27
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT02621385. Inclusion in this directory is not an endorsement.