A Study to Test How Well Multiple Doses of BI 765423 Are Tolerated by Healthy Men
- Registration Number
- NCT06232252
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics of BI 765423 in healthy male subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 38
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dose group (DG) 3 (medium dose) Placebo matching BI 765423 - Dose group (DG) 4 (high dose) BI 765423 - Dose group (DG) 4 (high dose) Placebo matching BI 765423 - Dose group (DG) 1 (very low dose) BI 765423 - Dose group (DG) 1 (very low dose) Placebo matching BI 765423 - Dose group (DG) 2 (low dose) BI 765423 - Dose group (DG) 2 (low dose) Placebo matching BI 765423 - Dose group (DG) 3 (medium dose) BI 765423 -
- Primary Outcome Measures
Name Time Method Percentage of subjects treated with BI 765423 who experience any treatment-emergent adverse event assessed as drug-related by the investigator up to 145 days for DG 1 and 2, up to 159 days for DG 3 and 4
- Secondary Outcome Measures
Name Time Method AUCτ (area under the concentration-time curve of the analyte in serum over a uniform dosing interval τ) up to 336 hours for DG 1 and 2, up to 673 hours for DG 3 and 4 Cmax (maximum measured concentration of the analyte in serum) up to 141 days for DG 1 and 2, up to 155 days for DG 3 and 4
Trial Locations
- Locations (1)
SGS Life Science Services - Clinical Research
🇧🇪Edegem, Belgium