The Effect of Multiple Doses of BI 187004 on the Single-dose Pharmacokinetics of Repaglinide and Bupropion in Healthy Male Volunteers

NCT ID: NCT02305901

Last Updated: 2015-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-03-31

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Repaglinide + Bupropion + BI 187004

repaglinide tablets and bupropion tablets with and without concomitant administration of BI 187004

Group Type: EXPERIMENTAL

repaglinide

Intervention Type: DRUG

single dose on day 1 of visits 2 and 3

BI 187004 tablet

Intervention Type: DRUG

multiple doses on days 8-13 of visit 2 and days 1-7 of visit 3

bupropion extended release tablet

Intervention Type: DRUG

single dose on day 3 of visits 2 and 3

Interventions

repaglinide

single dose on day 1 of visits 2 and 3

Intervention Type: DRUG

BI 187004 tablet

multiple doses on days 8-13 of visit 2 and days 1-7 of visit 3

Intervention Type: DRUG

bupropion extended release tablet

single dose on day 3 of visits 2 and 3

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1307.20.1 Boehringer Ingelheim Investigational Site

Biberach, , Germany

Countries

Germany

Other Identifiers

2013-005030-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1307.20

Identifier Type: -

Identifier Source: org_study_id