Trials / Terminated
TerminatedNCT04445090
A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated and How Food Influences the Amount of BI 1569912 in the Blood
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 1569912 in Healthy Male Subjects (Single-blind, Partially Randomized Within Dose Groups, Placebo-controlled, Parallel-group Design) With an Additional Relative Bioavailability/ Food Effect Part (Open-label, Randomized, Three-way Crossover Design)
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 68 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
SRD-Part: To investigate safety, tolerability, pharmacokinetics and pharmacodynamics following single rising doses (SRD) of BI 1569912 BA/FE-Part: To investigate (a) the relative bioavailability (BA) of BI 1569912 and (b) the influence of food (FE) on the relative bioavailability of BI 1569912
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BI 1569912 | BI 1569912 |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2020-07-21
- Primary completion
- 2021-09-10
- Completion
- 2021-09-10
- First posted
- 2020-06-24
- Last updated
- 2021-11-12
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT04445090. Inclusion in this directory is not an endorsement.