Healthy
Conditions
Brief summary
To assess the influence of BI 187004 on pharmacokinetics of CYP2C8 and CYP2B6 probe drugs repaglinide and bupropion as a means of predicting drug-drug interactions.
Interventions
DRUGrepaglinide
single dose on day 1 of visits 2 and 3
DRUGBI 187004 tablet
multiple doses on days 8-13 of visit 2 and days 1-7 of visit 3
DRUGbupropion extended release tablet
single dose on day 3 of visits 2 and 3
Sponsors
Boehringer Ingelheim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests 2. Age of 18 to 55 years (incl.) 3. Body mass index (BMI) of 18.5 to 29.9 kg/m2 (incl.) 4. Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
Exclusion criteria
1. Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator 2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm 3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance 4. Any evidence of a concomitant disease judged as clinically relevant by the investigator 5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders 6. Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair) 7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders Further
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve of repaglinide in plasma over the time interval from 0 to the last quantifiable data point | up to 48 h post dose |
| Maximum measured concentration of repaglinide in plasma | up to 48 h post dose |
| Area under the concentration-time curve of total bupropion in plasma over the time interval from 0 to the last quantifiable data point | up to 119 h post dose |
| Area under the concentration-time curve of S-bupropion in plasma over the time interval from 0 to the last quantifiable data point | up to 119 h post dose |
| Maximum measured concentration of total bupropion in plasma | up to 119 h post dose |
| Maximum measured concentration of S-bupropion in plasma | up to 119 h post dose |
Countries
Germany
Outcome results
None listed