Indivior Inc.
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.
Healthy
INDV-2000
Midazolam
Phase 1
Study Type : | Interventional |
Estimated Enrollment : | 20 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
Official Title : | 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 |
Actual Study Start Date : | March 15, 2023 |
Estimated Primary Completion Date : | May 1, 2023 |
Estimated Study Completion Date : | May 1, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: INDV-2000 BID + Midazolam Participants will receive a single oral dose of 5 mg midazolam on Day 1. Participants will receive 400 mg INDV-2000 twice a day (BID) from Days 2 to 15. On Day 15 participants will also receive a single oral dose of 5 mg midazolam co-administered with the INDV-2000 morning dose. |
Drug: INDV-2000 Other: Midazolam |
Ages Eligible for Study: | 18 Years to 55 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Celerion
Tempe, Arizona, United States, 85283