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

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02109679
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arms: 3
• Duration (Months): 2
• Patients Per Site Per Month: 8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: metformin; Drug: BI 187004; Drug: BI 187004; Drug: metformin	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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 (an Open-label, Randomised, Two-sequence Crossover Study)
• Study Start Date: May 1, 2014
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment A multiple doses BI 187004	Drug: BI 187004; multiple doses BI 187004 given as tablets
Experimental: Treatment B multiple doses BI 187004 + multiple doses metformin	Drug: BI 187004; multiple doses BI 187004 given as tablets; Drug: metformin; multiple doses metformin given as tablet
Experimental: Treatment C multiple doses metformin	Drug: metformin; multiple doses metformin given as tablet

Outcome Measures

Primary Outcome Measures

1. AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) for BI 187004 [up to 24 hours postdose]

2. AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) for metformin [up to 12 hours postdose]

3. Cmax,ss (Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) for BI 187004 [up to 24 hours postdose]

4. Cmax,ss (Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) for metformin [up to 12 hours postdose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	1307.7.1 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: NCT02109679
• Other Study ID Numbers: 1307.7; 2013-004628-13
• First Posted: Apr 10, 2014
• Last Update Posted: Jan 27, 2016
• Last Verified: Jan 1, 2016

• Additional relevant MeSH terms: Metformin

Study Results

No Results Posted as of Jan 27, 2016