Trials / Completed
CompletedNCT05833139
A Study in Healthy Men to Test How Itraconazole Influences the Amount of Zongertinib (BI 1810631) in the Blood
The Effect of Multiple Doses of Itraconazole on the Pharmacokinetics of a Single Oral Dose of BI 1810631 in Healthy Male Subjects (an Open-label, Two-period, Fixed-sequence Trial)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (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 of multiple doses of the strong CYP3A inhibitor and recommended P-glycoprotein (P-gp) inhibitor itraconazole on the pharmacokinetics of a single dose of zongertinib in plasma following oral administration.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Zongertinib | Zongertinib |
| DRUG | Itraconazole | Itraconazole |
Timeline
- Start date
- 2023-04-14
- Primary completion
- 2023-06-12
- Completion
- 2023-06-12
- First posted
- 2023-04-27
- Last updated
- 2025-09-22
- Results posted
- 2025-09-22
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT05833139. Inclusion in this directory is not an endorsement.