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Completed

NCT Number: NCT02276365

Bioavailability of BI 10773 and Pioglitazone in Healthy Male Volunteers

The objective of the study was to investigate whether there is a drug-drug interaction between BI 10773 and pioglitazone when co-administered as multiple oral doses. Therefore, the relative bioavailabilities of BI 10773 and pioglitazone were determined when both drugs were given in combination compared with BI 10773 and pioglitazone 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 males according to the following criteria:
  • Based upon a complete medical history, including the physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead ECG (electrocardiogram), clinical laboratory tests
  • Age 18 to 50 years (incl.)
  • BMI 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 (more than 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 (more than 10 cigarettes or more than 3 cigars or more than 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)
  • ALT (Alanine transaminase) outside the normal range or any other laboratory value outside the reference range that is of clinical relevance
  • Inability to comply with dietary regimen of trial site
  • Galactose or lactose intolerance, galactose or glucose malabsorption

Treatment and study plan

BI 10773

Drug

pioglitazone

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 10 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 10 days

Secondary outcomes

  1. Abnormal findings in physical examination

    Time frame: Baseline and up to 10 days after last study drug administration

  2. Changes from baseline in vital signs (Blood pressure, pulse rate)

    Time frame: Baseline and up to 10 days after last study drug administration

  3. Changes from baseline in 12-lead ECG (electrocardiogram)

    Time frame: Baseline and up to 10 days after last study drug administration

  4. Changes in clinical laboratory tests

    Time frame: Baseline and up to 10 days after last study drug administration

  5. Incidence of adverse events

    Time frame: up to 35 days

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

    Time frame: Within 3-10 days after last study drug administration

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

    Time frame: up to 10 days

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

    Time frame: up to 10 days

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

    Time frame: up to 10 days

  10. 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 10 days

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

    Time frame: up to 10 days

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

    Time frame: up to 10 days

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

    Time frame: up to 10 days

  14. 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

  15. 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

  16. CLR,ss (renal clearance of the analyte at steady state)

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

  17. UGE0-24 (Urinary glucose excretion of the analyte in urine over the time interval from time zero to 24 h)

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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Relative Bioavailability of Both BI 10773 50 mg and Pioglitazone 45 mg After Co-administration Compared to BI 10773 and Pioglitazone Alone in Healthy Male Volunteers (an Open-label, Randomised, Crossover, Clinical Phase I Study)

Important dates

Study start
2009
Primary completion
2009
First posted
Oct 28, 2014
Registry last updated
Oct 28, 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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