The Effect of Multiple Doses of BI 187004 on the Single-dose Pharmacokinetics of Repaglinide and Bupropion in Healthy Male Volunteers
Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: repaglinide (Drug); BI 187004 tablet (Drug); bupropion extended release tablet (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Boehringer Ingelheim Official(s) and/or principal investigator(s): Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim
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.
Clinical Details
Official title: The Effect of Multiple Doses of BI 187004 on the Single-dose Pharmacokinetics of Repaglinide and Bupropion Following Oral Administration in Healthy Male Subjects (an Open-label, One-sequence Trial)
Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Area under the concentration-time curve of repaglinide in plasma over the time interval from 0 to the last quantifiable data pointMaximum measured concentration of repaglinide in plasma Area under the concentration-time curve of total bupropion in plasma over the time interval from 0 to the last quantifiable data point Area under the concentration-time curve of S-bupropion in plasma over the time interval from 0 to the last quantifiable data point Maximum measured concentration of total bupropion in plasma Maximum measured concentration of S-bupropion in plasma
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Male.
Criteria:
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 exclusion criteria may apply.
Locations and Contacts
1307.20.1 Boehringer Ingelheim Investigational Site, Biberach, Germany
Additional Information
Starting date: December 2014
Last updated: May 10, 2015
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