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Completed

NCT Number: NCT01286571

Bioavailability and Pharmacokinetics of BI 135585 XX Administered as Tablet With and Without Food

The objective of this study is to investigate the effect of food on the relative bioavailability of a 50 mg BI 135585 XX tablet.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

1283.3.1 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

Exclusion criteria

  • Any relevant deviation from healthy conditions

Treatment and study plan

BI 135585

Drug

one oral single dose per subject

Primary outcomes

  1. Area under the concentration-time curve of BI 135585 in plasma over the time interval from 0 hours extrapolated to infinity

    Time frame: up to 144 hours post treatment

  2. Maximum measured concentration of the analyte in plasma of BI 135585 in plasma over the time interval from 0 hours extrapolated to infinity

    Time frame: up to 144 hours post treatment

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: up to 144 hours post treatment

  2. Physical examination (occurrence of findings)

    Time frame: up to 14 days post treatment

  3. %AUCtz-∞ (percentage of AUC0-∞ obtained by extrapolation)

    Time frame: up to 144 hours post treatment

  4. tmax (time from dosing to maximum measured concentration)

    Time frame: up to 144 hours post treatment

  5. λz (terminal rate constant in plasma)

    Time frame: up to 144 hours post treatment

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

    Time frame: up to 144 hours post treatment

  7. MRTpo (mean residence time of the analyte in the body after oral administration)

    Time frame: up to 144 hours post treatment

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

    Time frame: up to 144 hours post treatment

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

    Time frame: up to 144 hours post treatment

  10. Vital signs (blood pressure, pulse rate)

    Time frame: up to 14 days post treatment

  11. 12-lead ECG (electrocardiogram)

    Time frame: up to 14 days post treatment

  12. Clinical laboratory parameters (haematology, enzymes, substrates, electrolytes, hormones of the HPA axis and the thyroid gland, and urinalysis)

    Time frame: up to 14 days post treatment

  13. Incidence and severity of Adverse events

    Time frame: up to 14 days post treatment

  14. Assessment of tolerability by the investigator

    Time frame: up to 14 days post treatment

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Bioavailability and Pharmacokinetics of 50 mg BI 135585 XX Administered as Tablet With and Without Food to Healthy Male Volunteers (an Open-label, Randomised, Single-dose, Two-way Crossover Study)

Important dates

Study start
2011
Primary completion
2011
First posted
Jan 31, 2011
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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