Relative Bioavailability of a BI 187004 Tablet Formulation in Comparison With an Oral Solution and the Influence of Food on the Tablet Formulation in Healthy Volunteers
- Registration Number
- NCT02161432
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
To determine the relative bioavailability of an BI 187004 tablet formulation compared to an oral solution of BI 187004 and to assess the influence of food on the bioavailability of the tablet formulation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 17
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment C BI 187004 single dose of BI 187004 in fed state Treatment A BI 187004 single dose of BI 187004 in fasted state Treatment B BI 187004 single dose of BI 187004
- Primary Outcome Measures
Name Time Method Cmax (maximum measured concentration of the analyte in plasma) of BI 187004 up to 17 days postdose AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) of BI 187004 up to 17 days postdose
- Secondary Outcome Measures
Name Time Method AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) up to 17 days postdose
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 mechanism of action of BI 187004 in modulating its target in healthy volunteers?
How does the tablet formulation of BI 187004 compare to oral solution in terms of Cmax and AUC parameters?
Are there specific biomarkers associated with enhanced bioavailability of BI 187004 when administered with food?
What adverse events are commonly reported with BI 187004 and how are they managed in clinical settings?
How does BI 187004's pharmacokinetic profile compare to other PDE4 inhibitors in phase 1 trials?
Trial Locations
- Locations (1)
1307.3.1 Boehringer Ingelheim Investigational Site
🇩🇪Biberach, Germany
1307.3.1 Boehringer Ingelheim Investigational Site🇩🇪Biberach, Germany