Trials / Completed
CompletedNCT04716894
A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 474121 in the Blood
Effect of Itraconazole on the Pharmacokinetics of a Single Oral Dose of BI 474121 in Healthy Male Subjects (an Open-label, Two-period Fixed Sequence Design Study)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- Male
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
The main objective of this trial is to investigate the effect on the exposure of BI 474121 in plasma when given as oral single dose together with multiple oral doses of itraconazole (Test, T) as compared to when given alone as oral single dose (Reference, R).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BI 474121 | BI 474121 oral solution |
| DRUG | Itraconazole | Itraconazole oral solution |
Timeline
- Start date
- 2021-02-01
- Primary completion
- 2021-04-01
- Completion
- 2021-04-01
- First posted
- 2021-01-20
- Last updated
- 2024-03-08
- Results posted
- 2024-03-08
Locations
1 site across 1 country: Germany
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04716894. Inclusion in this directory is not an endorsement.