A Study in Healthy Men to Test How Well Different Doses of BI 3731579 Are Tolerated
- Registration Number
- NCT06429137
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3731579 in healthy male subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 63
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI 3731579 dose group 8 BI 3731579 - Placebo Matching placebo to BI 3731579 - BI 3731579 dose group 1 BI 3731579 - BI 3731579 dose group 2 BI 3731579 - BI 3731579 dose group 3 BI 3731579 - BI 3731579 dose group 4 BI 3731579 - BI 3731579 dose group 6 BI 3731579 - BI 3731579 dose group 7 BI 3731579 - BI 3731579 dose group 5 BI 3731579 -
- Primary Outcome Measures
Name Time Method Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator up to 14 days
- Secondary Outcome Measures
Name Time Method 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 Maximum measured concentration of the analyte in plasma (Cmax) up to 4 days 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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular targets and mechanisms of action for BI 3731579 in phase 1 clinical trials?
How does BI 3731579 compare to other investigational drugs in Boehringer Ingelheim's phase 1 portfolio for healthy subjects?
What pharmacokinetic parameters are being evaluated in NCT06429137 for BI 3731579 tablet formulations?
Are there any known biomarkers associated with the safety or efficacy of BI 3731579 in preclinical studies?
What adverse event profiles have been observed in similar phase 1 trials of novel compounds by Boehringer Ingelheim?
Trial Locations
- Locations (1)
Humanpharmakologisches Zentrum Biberach
🇩🇪Biberach, Germany
Humanpharmakologisches Zentrum Biberach🇩🇪Biberach, Germany