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

NCT02109679 | Completed Phase 1

• 2 other identifiers: 1307.72013-004628-13
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

Treatment A

EXPERIMENTAL

multiple doses BI 187004

Drug: BI 187004

Treatment B

EXPERIMENTAL

multiple doses BI 187004 + multiple doses metformin

Drug: BI 187004; Drug: metformin

Treatment C

EXPERIMENTAL

multiple doses metformin

Drug: metformin

Interventions

metformin DRUG

multiple doses metformin given as tablet

Treatment C

BI 187004 DRUG

multiple doses BI 187004 given as tablets

Treatment A

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects
• Subjects must be able to understand and comply with study requirements
• Age of 18 to 50 years
• Body mass index (BMI) of 18.5 to 29.9 kg/m2

You may not qualify if:

• 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
• 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
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• Any evidence of a concomitant disease judged as clinically relevant by the investigator
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication (except appendectomy and simple hernia repair)
• Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1307.7.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Location

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2014
• First Posted: April 10, 2014
• Study Start: May 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: January 27, 2016

Record last verified: 2016-01

Locations

DE (1)