Trials / Completed
CompletedNCT03971695
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 706321
Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BI 706321 in Healthy Male Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 73 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The main objectives are: * Part I: To investigate safety, tolerability, and pharmacokinetics (PK) of BI 706321 in healthy male subjects following oral administration of single rising doses. * Part II: The relative bioavailability of BI 706321 after administration of tablets and capsules under fasted conditions will be compared with each other and the effect of food on the tablet bioavailability will be investigated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BI 706321 | Capsule or Oral Solution |
| DRUG | Placebo | Capsule or Oral solution |
Timeline
- Start date
- 2019-06-18
- Primary completion
- 2020-12-04
- Completion
- 2020-12-04
- First posted
- 2019-06-03
- Last updated
- 2025-09-18
- Results posted
- 2025-09-18
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT03971695. Inclusion in this directory is not an endorsement.