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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: repaglinide; Drug: BI 187004 tablet; Drug: bupropion extended release tablet

• Registration Number: NCT02305901
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-01
• Study First Submitted QC: 2014-12-01
• Study First Posted: 2014-12-03
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-10
• Last Update Posted: 2015-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Repaglinide + Bupropion + BI 187004	BI 187004 tablet	repaglinide tablets and bupropion tablets with and without concomitant administration of BI 187004
Repaglinide + Bupropion + BI 187004	bupropion extended release tablet	repaglinide tablets and bupropion tablets with and without concomitant administration of BI 187004
Repaglinide + Bupropion + BI 187004	repaglinide	repaglinide tablets and bupropion tablets with and without concomitant administration of BI 187004

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

1307.20.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach, Germany