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Completed

NCT Number: NCT02172222

Relative Bioavailability of BI 10773 and Linagliptin in Healthy Male Volunteers

Study to investigate the relative bioavailability of BI 10773 and of linagliptin after concomitant multiple oral administration of 50 mg BI 10773 tablets and 5 mg linagliptin in comparison to 50 mg BI 10773 and 5 mg linagliptin 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 and physical examination including vital signs (BP (blood pressure), PR (pulse rate)), 12-lead ECG (electrocardiogram) and clinical laboratory tests
  • Age 18 to 50 years (inclusive)
  • BMI 18.5 to 29.9 kg/m2 (inclusive)
  • 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

Linagliptin

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 day 8

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

    Time frame: up to day 8

Secondary outcomes

  1. tmax,ss (time from last dosing to the maximum measured concentration of each analyte in plasma at steady state)

    Time frame: up to day 8

  2. Urine glucose excretion (UGE)

    Time frame: Pre-dose and 0-2, 2-4, 4-8, 8-12, 12-24 hours after the last dosing of each visit

  3. Plasma DPP-4 (Dipeptidyl-peptidase 4) inhibition

    Time frame: 2 hours and 24 hours after last administration of study drug

  4. Changes from baseline in physical examination

    Time frame: Baseline and within 5 days after last study drug administration

  5. Changes from baseline in vital signs (blood pressure, pulse rate)

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

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

    Time frame: Baseline and within 5 days after last study drug administration

  7. Changes from baseline clinical laboratory tests

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

  8. Incidence of adverse events

    Time frame: Up to 56 days

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

    Time frame: Within 5 days after last study drug administration

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Relative Bioavailability of Multiple Doses BI 10773 50 mg and Linagliptin 5 mg After Concomitant Administration Compared to Multiple Doses of BI 10773 50 mg and Linagliptin 5mg Administered 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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