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Completed

NCT Number: NCT02183363

Bioavailability of BI 1356 After Single Oral Administration Given as Different Tablet Formulation in Healthy Male Volunteers

Study to investigate the relative bioavailability of 5 mg BI 1356 as tablet formulations (Trial formulation) TF II and Intended final formulation (iFF) vs. 5 mg BI 1356 as tablet TF IIb

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Key information

Conditions

Age range

21 year–55 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 subjects 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 Electrocardiogram (ECG), clinical laboratory tests
  • No findings deviating from normal and of clinical relevance
  • No evidence of a clinically relevant concomitant disease
  • Age ≥21 and Age ≤55 years
  • BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
  • Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

Exclusion criteria

  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Surgery of 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 allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
  • 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
  • Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days 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 60 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 study centre

Treatment and study plan

BI 1356 - Tablet TFII

Drug

BI 1356 - Tablet iFF

Drug

BI 1356 - Tablet TFIIb

Drug

Primary outcomes

  1. AUC0-24 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours)

    Time frame: predose, up to 24 hours

Secondary outcomes

  1. Cmax (maximum measured concentration of the analyte in plasma)

    Time frame: predose, up to 264 hours

  2. AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

    Time frame: predose, up to 264 hours

  3. AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)

    Time frame: predose, up to 264 hours

  4. AUCt1-t2 (Partial area under the concentration time curve of the analyte in plasma over the time interval t1 to t2)

    Time frame: predose, up to 264 hours

  5. C24 (plasma concentration of the analyte 24 hours after dosing)

    Time frame: predose, up to 264 hours

  6. tmax (time from dosing to the maximum concentration of the analyte in plasma)

    Time frame: predose, up to 264 hours

  7. λz (terminal rate constant in plasma)

    Time frame: predose, up to 264 hours

  8. t1/2 (terminal half-life of the analyte in plasma)

    Time frame: predose, up to 264 hours

  9. MRTpo (mean residence time of the analyte in the body after po administration)

    Time frame: predose, up to 264 hours

  10. CL/F (apparent clearance of the analyte in the plasma after extravascular administration)

    Time frame: predose, up to 264 hours

  11. Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)

    Time frame: predose, up to 264 hours

  12. Changes in Dipeptidyl-peptidase-IV (DPP-IV) activity in plasma

    Time frame: predose, up to 264 hours

  13. Changes in plasma glucose levels

    Time frame: predose, up to 264 hours

  14. Number of patients with adverse events

    Time frame: up to 18 days following last drug administration

  15. Number of patients with abnormal findings in physical examination

    Time frame: up to 18 days following last drug administration

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

    Time frame: up to 18 days following last drug administration

  17. Number of patients with abnormal changes 12-lead ECG (electrocardiogram)

    Time frame: up to 18 days following last drug administration

  18. Number of patients with abnormal changes in laboratory parameters

    Time frame: up to 18 days following last drug administration

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

    Time frame: up to 18 days following last drug administration

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Bioavailability of BI 1356 After Single Oral Administration of 5 mg BI 1356 Given as Tablet Formulation TF IIb Relative to Tablet Formulation TF II and Tablet Formulation iFF in Healthy Male Volunteers (an Open Label, Randomised, Single-dose, Three-way Crossover Study)

Important dates

Study start
2007
Primary completion
2007
First posted
Jul 8, 2014
Registry last updated
Jul 8, 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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