A Study in Healthy Japanese Men to Test How Well Different Doses of BI 1291583 Are Tolerated
- Registration Number
- NCT05183347
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1291583 in healthy male Japanese subjects following oral administration of single rising doses and multiple doses.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 36
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SRD: Dose Group 1 BI 1291583 SRD: single-rising dose SRD: Dose Group 2 BI 1291583 SRD: single-rising dose MD: Dose Group 4 BI 1291583 MD: multiple doses Placebo Placebo - SRD: Dose Group 3 BI 1291583 SRD: single-rising dose
- Primary Outcome Measures
Name Time Method Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator up to 65 days
- Secondary Outcome Measures
Name Time Method SRD: Area under the concentration-time curve of BI 1291583 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) up to 29 days SRD: single-rising dose
MD: After the last dose: Maximum measured concentration of BI 1291583 in plasma at steady state (Cmax,ss) at day 28 MD: multiple doses
SRD: Maximum measured concentration of BI 1291583 in plasma (Cmax) up to 29 days SRD: single-rising dose
MD: After the first dose: Area under the concentration-time curve of BI 1291583 in plasma over a uniform dosing interval τ (AUCτ,1) up to 24 hours MD: multiple doses
MD: After the first dose: Maximum measured concentration of BI 1291583 in plasma (Cmax,1) up to 24 hours MD: multiple doses
MD: After the last dose: Area under the concentration-time curve of BI 1291583 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) at day 28 MD: multiple doses
Trial Locations
- Locations (1)
SOUSEIKAI Sumida Hospital
🇯🇵Tokyo, Sumida-ku, Japan