Relative Bioavailability of Multiple Oral Doses of BI 187004 and Metformin After Co-administration Compared to Multiple Oral Doses of BI 187004 Alone and Metformin Alone in Healthy Male Subjects

NCT ID: NCT02109679

Last Updated: 2016-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2014-07-31

Brief Summary

To investigate bioavailability of BI 187004 and of metformin after concomitant multiple oral administration of 240 mg BI 187004 q.d. and 1000 mg metformin b.i.d. in comparison to BI 187004 and metformin given alone.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment A

multiple doses BI 187004

Group Type: EXPERIMENTAL

BI 187004

Intervention Type: DRUG

multiple doses BI 187004 given as tablets

Treatment B

multiple doses BI 187004 + multiple doses metformin

Group Type: EXPERIMENTAL

BI 187004

Intervention Type: DRUG

multiple doses BI 187004 given as tablets

metformin

Intervention Type: DRUG

multiple doses metformin given as tablet

Treatment C

multiple doses metformin

Group Type: EXPERIMENTAL

metformin

Intervention Type: DRUG

multiple doses metformin given as tablet

Interventions

metformin

multiple doses metformin given as tablet

Intervention Type: DRUG

BI 187004

multiple doses BI 187004 given as tablets

Intervention Type: DRUG

BI 187004

multiple doses BI 187004 given as tablets

Intervention Type: DRUG

metformin

multiple doses metformin given as tablet

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy male subjects

2. Subjects must be able to understand and comply with study requirements

3. Age of 18 to 50 years

4. Body mass index (BMI) of 18.5 to 29.9 kg/m2

Exclusion Criteria

1. Any finding in the medical examination (including BP, pulse rate (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 or 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. Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication (except appendectomy and simple hernia repair)

7. Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 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

1307.7.1 Boehringer Ingelheim Investigational Site

Biberach, , Germany

Countries

Germany

Other Identifiers

2013-004628-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1307.7

Identifier Type: -

Identifier Source: org_study_id