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Completed

NCT Number: NCT01189175

Study in Healthy Male Subjects to Investigate Whether Ketoconazole Affects Plasma Exposure of BI 113823

The objective of the study is to investigate whether ketoconazole affects plasma exposure of BI 113823

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

1272.5.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

healthy male subjects

Treatment and study plan

BI 113823 + Ketokonazole

Drug

5 days ketokonazole with single oral dose of BI 113823 on day 3

BI 113823

Drug

single oral dose

Primary outcomes

  1. AUC0-∞(area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) of BI 113823

    Time frame: 2 weeks

  2. Cmax (maximum measured concentration of the analyte in plasma) of BI 113823

    Time frame: 2 weeks

Secondary outcomes

  1. 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: 2 weeks

  2. Number of participants with clinically significant changes in physical examination

    Time frame: up to 24 days

  3. Number of participants with clinically significant changes in vital signs

    Time frame: up to 24 days

  4. Number of participants with clinically significant changes in ECG

    Time frame: up to 24 days

  5. Number of participants with clinically significant changes in laboratory tests

    Time frame: up to 24 days

  6. Occurrence of adverse events

    Time frame: up to 24 days

  7. Assessment of tolerability by the investigator

    Time frame: up to 24 days

  8. AUCt1-t2 (Area under the concentration time curve of the analyte in plasma over the time interval t1 to t2)

    Time frame: 2 weeks

  9. AUC0-tmax (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to median tmax

    Time frame: 2 weeks

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

    Time frame: 2 weeks

  11. λz (terminal rate constant in plasma) t1/2 (terminal half-life of the analyte in plasma

    Time frame: 2 weeks

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

    Time frame: 2 weeks

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

    Time frame: 2 weeks

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

    Time frame: 2 weeks

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

    Time frame: 2 weeks

  16. Ae0-24 (amount of analyte that is eliminated in urine from the time interval 0 to 24)

    Time frame: visit 2, day 1 and visit 4 day 1

  17. fe0-24 (fraction of administered drug excreted unchanged in urine from time point 0 to 24

    Time frame: visit 2, day 1 and visit 4 day 1

  18. CLR,0-24 (renal clearance of the analyte in plasma from the time point 0 until the time point 24)

    Time frame: visit 2, day 1 and visit 4 day 1

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Relative Bioavailability of a Single Oral Dose of BI 113823 (50 mg qd) When Administered Alone or in Combination With Multiple Oral Doses of Ketoconazole (200 mg Bid) in Healthy Male Volunteers (an Open Label, Two Periods, Fixed-sequence, Clinical Phase I Study)

Important dates

Study start
2010
Primary completion
2010
First posted
Aug 26, 2010
Registry last updated
Nov 1, 2013

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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