Trials / Completed
CompletedNCT03783000
A Study in Healthy Men to Measure the Amount of BI 425809 in the Blood When Taken as a Tablet
Investigation of Pharmacokinetics and Absolute Oral Bioavailability of BI 425809 Administered as an Oral Dose With an Intravenous Microtracer Dose of [C-14]-BI 425809 in Healthy Male Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- Male
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
The primary objective of this trial is to investigate the absolute oral bioavailability of BI 425809 administered as tablet (Test, T) compared to \[C-14\]-BI 425809 administered as intravenous microtracer (Reference, R).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BI 425809 | One 25 mg film coated tablet administered with 240 milliliters of water after an overnight fast of at least 10 hours. |
| DRUG | [C-14]-BI 425809 | Intravenous micro-tracer infusion of 30 μg BI 425809 (14-C) administered 4 hours after treatment T. |
Timeline
- Start date
- 2019-01-15
- Primary completion
- 2019-03-06
- Completion
- 2019-03-06
- First posted
- 2018-12-20
- Last updated
- 2026-03-27
- Results posted
- 2026-03-27
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT03783000. Inclusion in this directory is not an endorsement.