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

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)

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: BI 187004; Drug: metformin

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Biberach, Germany
    • 1307.7.1 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: April 8, 2014
• First Submitted That Met QC Criteria: April 8, 2014
• First Posted (Estimate): April 10, 2014

Study Record Updates

• Last Update Posted (Estimate): January 27, 2016
• Last Update Submitted That Met QC Criteria: January 26, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: 1307.7; 2013-004628-13 (EudraCT Number: EudraCT)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No