Relative Bioavailability BI 10773 and Metformin in Healthy Male Volunteers

NCT02172248 | Completed Phase 1

• 1 other identifier: 1245.6
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective was to investigate a possible drug-drug interaction between BI 10773 and metformin when co-administered as multiple oral doses. Therefore, the relative bioavailabilities of BI 10773 and metformin were determined when both drugs were given in combination compared with BI 10773 or metformin given alone.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)

  up to 7 days

• Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)

  up to 7 days

Secondary Outcomes (18)

• C24,N (concentration of analyte in plasma at 24 hours post-drug administration after administration of the Nth dose) of BI 10773

  up to 7 days

• C12,N (concentration of analyte in plasma at 12 hours post-drug administration after administration of the Nth dose) of metformin

  up to 7 days

• λz,ss (terminal half-life of the analyte in plasma)

  up to 7 days

• t½,ss (terminal half-life of the analyte in plasma at steady state)

  up to 7 days

• tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state over a uniform dosing interval τ)

  up to 7 days

Study Arms (2)

Sequence ABC

EXPERIMENTAL

1. Treatment A: BI 10773 once daily from day 1 to 5 2. Treatment B: BI 10773 once daily from day 1 to 4 and metformin twice daily from day 1 to 3 and once in the morning on day 4 3. Treatment C: metformin twice daily from day 1 to 3 and once in the morning on day 4

Drug: BI 10773; Drug: Metformin

Sequence CAB

EXPERIMENTAL

1. Treatment C: metformin twice daily from day 1 to 3 and once in the morning on day 4 2. Treatment A: BI 10773 once daily from day 1 to 5 3. Treatment B: BI 10773 once daily from day 1 to 4 and metformin twice daily from day 1 to 3 and once in the morning on day 4

Drug: BI 10773; Drug: Metformin

Interventions

BI 10773 DRUG

Sequence ABC; Sequence CAB

Metformin DRUG

Sequence ABC; Sequence CAB

Eligibility Criteria

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

You may qualify if:

• Healthy male volunteers according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP (Blood Pressure), PR (Pulse Rate)), 12-lead ECG (Electrocardiogram), clinical laboratory tests
• Age 18 to 50 years (incl.)
• BMI (Body Mass Index) 18.5 to 29.9 kg/m2 (incl.)
• Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation

You may not qualify if:

• Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
• Any evidence of a clinically relevant concomitant disease
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of the gastrointestinal tract (except appendectomy)
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of relevant orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
• Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
• Participation in another trial with an investigational drug within two months prior to administration or during the trial
• Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (more than 30 g/day)
• Drug abuse
• Blood donation (more than 100 mL within four weeks prior to administration or during the trial)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

empagliflozin; Metformin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

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

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 24, 2014
• Study Start: January 1, 2009
• Primary Completion: March 1, 2009
• Last Updated: June 24, 2014

Record last verified: 2014-06