A Study to Test How Well Different Doses of BI 3810477 Are Tolerated by Healthy Men
- Registration Number
- NCT06631430
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3810477 in healthy male subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 24
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part A: BI 3810477 formulation A dose group 1 BI 3810477 single dose group 1 Part A: BI 3810477 formulation A dose group 2 BI 3810477 single dose group 2 Part A: BI 3810477 formulation A dose group 3 BI 3810477 single dose group 3 Part A: BI 3810477 formulation A dose group 4 BI 3810477 single dose group 4 Part A: BI 3810477 formulation A dose group 5 BI 3810477 single dose group 5 Part A: BI 3810477 formulation A dose group 6 BI 3810477 single dose group 6 Part A: BI 3810477 formulation A dose group 7 BI 3810477 single dose group 7 Part B: BI 3810477 formulation B dose group 1 BI 3810477 single dose group 1 Part B: BI 3810477 formulation B dose group 2 BI 3810477 single dose group 2 Part B: BI 3810477 formulation B dose group 3 BI 3810477 single dose group 3 Part A and Part B_Placebo Placebo single dose of placebo
- Primary Outcome Measures
Name Time Method Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator Up to Day 85
- Secondary Outcome Measures
Name Time Method Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) Up to Day 85 Maximum measured concentration of the analyte in plasma (Cmax) Up to Day 85
Trial Locations
- Locations (1)
SGS Life Science Services - Clinical Research
🇧🇪Edegem, Belgium