A Study in Healthy Men to Test Whether Zongertinib Influences the Amount of 4 Other Medicines (Dabigatran, Rosuvastatin, Metformin, and Furosemide) in the Blood
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: Dabigatran-etexilate
- Registration Number
- NCT06504862
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
For Part 1 of the trial, the main objective is to assess the effect of a single dose of zongertinib on the pharmacokinetics of a single dose of dabigatran-etexilate. For Part 2 of the trial, the main objective is to assess the effect of zongertinib at steady-state on the pharmacokinetics of a single dose of rosuvastatin, metformin and furosemide (administered as a cocktail).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 32
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Part 1: dabigatran-etexilate (Reference, R) then zongertinib and dabigatran-etexilate (Test, T) Zongertinib - Part 2: Drug cocktail (Reference, R) then zongertinib and drug cocktail (Test, T) Metformin hydrochloride Drug cocktail: Cocktail of rosuvastatin, metformin and furosemide Part 2: Drug cocktail (Reference, R) then zongertinib and drug cocktail (Test, T) Furosemide Drug cocktail: Cocktail of rosuvastatin, metformin and furosemide Part 1: dabigatran-etexilate (Reference, R) then zongertinib and dabigatran-etexilate (Test, T) Dabigatran-etexilate - Part 2: Drug cocktail (Reference, R) then zongertinib and drug cocktail (Test, T) Zongertinib Drug cocktail: Cocktail of rosuvastatin, metformin and furosemide Part 2: Drug cocktail (Reference, R) then zongertinib and drug cocktail (Test, T) Rosuvastatin Drug cocktail: Cocktail of rosuvastatin, metformin and furosemide
- Primary Outcome Measures
Name Time Method Part 1: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) Up to 3 days Part 2: Maximum measured concentration of the analyte in plasma (Cmax) Up to 4 days Part 1: Maximum measured concentration of the analyte in plasma (Cmax) Up to 3 days Part 2: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) Up to 4 days
- Secondary Outcome Measures
Name Time Method Part 2: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) up to 4 days Part 1: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) Up to 3 days
Trial Locations
- Locations (1)
Humanpharmakologisches Zentrum Biberach
🇩🇪Biberach, Germany