A Study to Test How Different Doses of BI 3731579 Are Tolerated by Healthy People
Phase 1
Recruiting
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT06716190
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics and pharmacodynamics of BI 3731579 in healthy volunteers following administration of multiple rising doses per day over 15 days.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MRD: BI 3731579 dose group 1 BI 3731579 MRD= Multiple rising doses MRD: BI 3731579 dose group 1 Midazolam MRD= Multiple rising doses MRD: BI 3731579 dose group 2 BI 3731579 - MRD: BI 3731579 dose group 2 Midazolam - MRD: BI 3731579 dose group 3 BI 3731579 - MRD: BI 3731579 dose group 3 Midazolam - MRD: BI 3731579 dose group 4 BI 3731579 - MRD: BI 3731579 dose group 4 Midazolam - MRD: Placebo matching BI 3731579 Placebo matching BI 3731579 - MRD: Placebo matching BI 3731579 Midazolam -
- Primary Outcome Measures
Name Time Method Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator up to Day 27.
- Secondary Outcome Measures
Name Time Method AUCτ,ss (area under the concentration-time curve of BI 3731579 in plasma at steady state over a uniform dosing interval τ) up to Day 19. Cmax,ss (maximum measured concentration of BI 3731579 in plasma at steady state over a uniform dosing interval τ) up to Day 19.
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 is the molecular target of BI 3731579 and how does it interact with CYP enzymes in healthy volunteers?
How does BI 3731579's pharmacokinetics compare to midazolam in CYP enzyme interaction studies?
Which biomarkers correlate with BI 3731579's pharmacodynamic effects in phase 1 trials?
What dose-related adverse events are reported in BI 3731579 phase 1 trials in healthy volunteers?
Are there other Boehringer Ingelheim drugs targeting similar pathways as BI 3731579 for therapeutic development?
Trial Locations
- Locations (1)
SGS Life Science Services - Clinical Research
🇧🇪Edegem, Belgium