Trials / Completed
CompletedNCT04789304
A Study to Test How Healthy Men Tolerate Different Doses of BI 1595043
Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 1595043 (Double-blind, Randomised, Placebocontrolled, Parallel Group Design) in Healthy Male Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- Male
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
The primary objectives of this trial are to investigate safety and tolerability of BI 1595043 in healthy male subjects following administration of multiple rising doses over 14 days. Secondary objectives are the exploration of pharmacokinetics (PK) of BI 1595043 after single and multiple dosing.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BI 1595043 | BI 1595043 |
| DRUG | Placebo | Placebo |
| DRUG | Midazolam | Midazolam |
Timeline
- Start date
- 2021-04-01
- Primary completion
- 2022-01-14
- Completion
- 2022-01-14
- First posted
- 2021-03-09
- Last updated
- 2024-02-21
- Results posted
- 2024-02-21
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT04789304. Inclusion in this directory is not an endorsement.