A Study in Healthy Men to Test How Well Different Doses of BI 3776528 Are Tolerated
- Registration Number
- NCT06745297
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The trial aims to study the safety, tolerability, and pharmacokinetics of single and multiple rising doses of BI 3776528.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 142
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Treatment group BI 3776528 - Placebo group Placebo matching BI 3776528 Applicable for part 1a and part 2 of the trial.
- Primary Outcome Measures
Name Time Method Part 1a and Part 2: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator up to 73 days Part 1b: AUC0-tz of BI 3776528 in plasma (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) up to 27 days Part 1b: Cmax of BI 3776528 in plasma (maximum measured concentration of the analyte in plasma) up to 27 days
- Secondary Outcome Measures
Name Time Method Part 1a: AUC0-∞ of BI 3776528 in plasma (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) up to 27 days Part 1a: Cmax of BI 3776528 in plasma up to 27 days Part 1b: AUC0-∞ of BI 3776528 in plasma up to 27 days Part 2: AUCτ,ss of BI 3776528 in plasma (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) up to 27 days Part 2: Cmin,ss of BI 3776528 in plasma (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ) up to 27 days Part 2: Cmax,ss of BI 3776528 in plasma (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) up to 27 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 molecular targets does BI 3776528 modulate in phase 1 trials involving healthy volunteers?
How does BI 3776528's pharmacokinetic profile compare to similar investigational drugs in phase 1 healthy volunteer studies?
Are there biomarkers predictive of adverse events or drug metabolism in BI 3776528 single/multiple dose trials?
What adverse event management strategies are specific to Boehringer Ingelheim's phase 1 BI 3776528 trials?
What combination therapies or competitor drugs are being developed for similar pharmacological pathways as BI 3776528?
Trial Locations
- Locations (1)
Charité Research Organisation GmbH
🇩🇪Berlin, Germany