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

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02305901
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arm: 1
• Duration (Months): 3
• Patients Per Site Per Month: 6.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: repaglinide; Drug: BI 187004 tablet; Drug: bupropion extended release tablet	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Dec 1, 2014
• Actual Primary Completion Date: Mar 1, 2015
• Actual Study Completion Date: Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Repaglinide + Bupropion + BI 187004 repaglinide tablets and bupropion tablets with and without concomitant administration of BI 187004	Drug: repaglinide; single dose on day 1 of visits 2 and 3; Drug: BI 187004 tablet; multiple doses on days 8-13 of visit 2 and days 1-7 of visit 3; Drug: bupropion extended release tablet; single dose on day 3 of visits 2 and 3

Outcome Measures

Primary Outcome Measures

1. 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]

2. Maximum measured concentration of repaglinide in plasma [up to 48 h post dose]

3. 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]

4. 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]

5. Maximum measured concentration of total bupropion in plasma [up to 119 h post dose]

6. Maximum measured concentration of S-bupropion in plasma [up to 119 h post dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts 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 exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	1307.20.1 Boehringer Ingelheim Investigational Site	Biberach		Germany

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

• Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT02305901
• Other Study ID Numbers: 1307.20; 2013-005030-38
• First Posted: Dec 3, 2014
• Last Update Posted: May 12, 2015
• Last Verified: May 1, 2015

• Additional relevant MeSH terms: Repaglinide; Bupropion

Study Results

No Results Posted as of May 12, 2015