A Study in Healthy Men to Test Whether BI 1815368 Influences the Amount of Metformin in the Body
- Registration Number
- NCT06655220
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The main objective of this trial is to investigate the effect on the exposure of metformin in plasma when administered as an oral multiple dose together with multiple oral doses of BI 1815368 (Test, T) as compared to when metformin is administered as an oral multiple dose alone (Reference, R).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 14
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Metformin hydrochloride alone (reference) followed by metformin hydrochloride + BI 1815368 (Test) Metformin hydrochloride - Metformin hydrochloride alone (reference) followed by metformin hydrochloride + BI 1815368 (Test) BI 1815368 - Metformin hydrochloride + BI 1815368 (Test) followed by metformin hydrochloride alone (reference) Metformin hydrochloride - Metformin hydrochloride + BI 1815368 (Test) followed by metformin hydrochloride alone (reference) BI 1815368 -
- Primary Outcome Measures
Name Time Method AUC τ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) Up to 2 days after last dose administration C max,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) Up to 2 days after last dose administration
- Secondary Outcome Measures
Name Time Method CL R,ss (renal clearance of the analyte from plasma at steady state) Up to 2 days after last dose administration
Trial Locations
- Locations (1)
Humanpharmakologisches Zentrum Biberach
🇩🇪Biberach, Germany