A study in healthy men to test whether BI 1015550 influences the amount of nintedanib and pirfenidone in the blood
Phase 1
- Conditions
- Healthy volunteer trialMedDRA version: 21.0Level: LLTClassification code: 10053349Term: Pharmacokinetic study Class: 10022891Therapeutic area: Not possible to specify
- Registration Number
- CTIS2023-505522-34-00
- Lead Sponsor
- Boehringer Ingelheim International GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 14
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
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 mechanisms does BI 1015550 modulate to alter nintedanib and pirfenidone pharmacokinetics in healthy volunteers?
How does BI 1015550 compare to other PDE4 inhibitors in drug-drug interaction profiles for antifibrotic therapies like nintedanib/pirfenidone?
Are CYP450 or transporter biomarkers predictive of nintedanib/pirfenidone blood concentration changes in CTIS2023-505522-34-00?
What adverse event management strategies are critical for PDE4 inhibitor-nintedanib/pirfenidone combinations in phase I trials?
What therapeutic synergies exist between BI 1015550 and standard-of-care antifibrotic agents in preclinical or clinical pharmacokinetic studies?