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OpenTrials
Completed

NCT Number: NCT01707940

Bioavailability of BI 144807 Given Alone and in Combination With Ketoconazole in Healthy Male Volunteers

This trial investigates the influence of oral ketoconazole on the pharmacokinetics and safety of BI 144807.

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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

1313.7.1 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

Ketoconazole

Drug

Ketoconazole 400 mg / day

BI 144807

Drug

BI144807 oral solution, intermediate dose

Primary outcomes

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

    Time frame: 0 to 48 hours after administration

  2. Maximum measured concentration of the analyte in plasma

    Time frame: 0 to 48 hours after administration

Secondary outcomes

  1. Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point

    Time frame: 0 to 48 hours after administration

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Relative Bioavailability of a Single Oral Dose of BI 144807 (Oral Solution) When Administered Alone or in Combination With Multiple Oral Doses of Ketoconazole (200 mg Tablet) in Healthy Male Subjects (an Open-label, Two-period, Fixed-sequence Trial)

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Oct 16, 2012
Registry last updated
May 16, 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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