Trials / Completed
CompletedNCT06327256
A Study in Healthy People to Test How Well Different Doses of BI 3000202 Are Tolerated and How They Affect the Way the Body Handles Midazolam
Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 3000202 in Healthy Male and Female Subjects (Double-blind, Randomised, Placebo-controlled, Parallel Group Design) and Evaluation of Midazolam Interaction in Healthy Male and Female Subjects (Nested, Open, Fixed-sequence, Intra-individual Comparison)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) following multiple rising doses of BI 3000202 and to investigate the effect of BI 3000202 on the metabolism of midazolam.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BI 3000202 | BI 3000202 |
| DRUG | Placebo | Placebo-matching BI 3000202 |
| DRUG | Midazolam | Midazolam |
Timeline
- Start date
- 2024-04-09
- Primary completion
- 2024-09-27
- Completion
- 2024-09-27
- First posted
- 2024-03-25
- Last updated
- 2024-11-13
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT06327256. Inclusion in this directory is not an endorsement.