Trials / Completed
CompletedNCT05694533
Study of Potential CYP3A4 Induction by INDV-2000 in Healthy Adults
An Open Label, Fixed-sequence Study to Evaluate the Potential CYP3A4 Induction Effect of INDV-2000 Using Oral Midazolam as a Probe in Healthy Adults Participants
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Indivior Inc. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to investigate the potential for cytochrome P450 (CYP) 3A4 induction after dosing with INDV-2000 via use of midazolam as a probe.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | INDV-2000 | Capsules administered orally twice a day |
| DRUG | Midazolam | Midazolam syrup administered orally on Days 1 and 15 |
Timeline
- Start date
- 2023-03-16
- Primary completion
- 2023-04-06
- Completion
- 2023-05-01
- First posted
- 2023-01-23
- Last updated
- 2024-05-28
- Results posted
- 2024-05-17
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05694533. Inclusion in this directory is not an endorsement.