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

NCT02305901 | Completed Phase 1

• 2 other identifiers: 1307.202013-005030-38
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Repaglinide + Bupropion + BI 187004

EXPERIMENTAL

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

Drug: repaglinide; Drug: BI 187004 tablet; Drug: bupropion extended release tablet

Interventions

repaglinide DRUG

single dose on day 1 of visits 2 and 3

Repaglinide + Bupropion + BI 187004

BI 187004 tablet DRUG

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

Repaglinide + Bupropion + BI 187004

bupropion extended release tablet DRUG

single dose on day 3 of visits 2 and 3

Repaglinide + Bupropion + BI 187004

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Age of 18 to 55 years (incl.)
• Body mass index (BMI) of 18.5 to 29.9 kg/m2 (incl.)
• Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

You may not qualify if:

• Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator
• 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
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• Any evidence of a concomitant disease judged as clinically relevant by the investigator
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)
• Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1307.20.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Location

MeSH Terms

Interventions

repaglinide

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2014
• First Posted: December 3, 2014
• Study Start: December 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: May 12, 2015

Record last verified: 2015-05

Locations

DE (1)