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Completed

NCT Number: NCT02172248

Relative Bioavailability BI 10773 and Metformin in Healthy Male Volunteers

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.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)
  • Excessive physical activities (within one week prior to administration or during the trial)
  • Any laboratory value outside the reference range that is of clinical relevance
  • Inability to comply with dietary regimen of trial site

Treatment and study plan

BI 10773

Drug

metformin

Drug

Primary outcomes

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

    Time frame: up to 7 days

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

    Time frame: up to 7 days

Secondary outcomes

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

    Time frame: up to 7 days

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

    Time frame: up to 7 days

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

    Time frame: up to 7 days

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

    Time frame: up to 7 days

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

    Time frame: up to 7 days

  6. MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration)

    Time frame: up to 7 days

  7. CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state)

    Time frame: up to 7 days

  8. Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration)

    Time frame: up to 7 days

  9. Aet1-t2,ss (amount of analyte eliminated in urine at steady state over a uniform dosing interval τ)

    Time frame: 1 hour pre-dose, 0-2, 2-4, 4-8, 8-12, 12-24 hours after last dosing

  10. fet1-t2,ss (fraction of analyte excreted unchanged in urine at steady state over a uniform dosing interval τ)

    Time frame: 1 hour pre-dose, 0-2, 2-4, 4-8, 8-12, 12-24 hours after last dosing

  11. CLR,ss (renal clearance of the analyte at steady state) of BI 10773 and metformin

    Time frame: 1 hour pre-dose, 0-2, 2-4, 4-8, 8-12, 12-24 hours after last dosing

  12. Urinary glucose excretion (UGE)

    Time frame: 1 hour pre-dose, 0-2, 2-4, 4-8, 8-12, 12-24 hours after last dosing

  13. Number of patients with abnormal findings in physical examination

    Time frame: Baseline and within 3-14 days after last study drug administration

  14. Number of patients with clinically significant changes in vital signs (Blood Pressure, Pulse Rate)

    Time frame: Baseline, day 1 and within 3-14 days after last study drug administration

  15. Number of patients with abnormal findings in 12-lead ECG (electrocardiogram)

    Time frame: Baseline and within 3-14 days after last study drug administration

  16. Number of patients with abnormal changes in clinical laboratory tests

    Time frame: Baseline, day 1, 4, 5 and within 3-14 days after last study drug administration

  17. Number of patients with adverse events

    Time frame: up to 40 days

  18. Assessment of tolerability by investigator on a 4-point scale

    Time frame: Within 3-14 days after last study drug administration

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Relative Bioavailability of Both BI 10773 and Metformin After Coadministration Compared to Multiple Oral Doses of BI 10773 (50 mg q.d.) Alone and Metformin (1000 mg b.i.d.) Alone to Healthy Male Volunteers (an Open-label, Randomised, Crossover, Clinical Phase I Study)

Important dates

Study start
2009
Primary completion
2009
First posted
Jun 24, 2014
Registry last updated
Jun 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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