Trials / Completed
CompletedNCT05965583
A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 1815368 in the Blood
Effect of Itraconazole on the Pharmacokinetics of a Single Oral Dose of BI 1815368 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 – 55 Years
- Healthy volunteers
- Accepted
Summary
The main objective of this trial is to investigate the effect on the exposure of BI 1815368 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 1815368 | BI 1815368 |
| DRUG | Itraconazole | Itraconazole |
Timeline
- Start date
- 2023-08-02
- Primary completion
- 2023-10-24
- Completion
- 2023-10-24
- First posted
- 2023-07-28
- Last updated
- 2023-11-03
Locations
1 site across 1 country: Germany
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05965583. Inclusion in this directory is not an endorsement.