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OpenTrials
Completed

NCT Number: NCT01652742

Study to Explore Pharmacokinetics and Pharmacodynamics of a Single Rising Dose of BI 135585 XX

To investigate the pharmacokinetics and pharmacodynamics of BI 135585 XX following single dose administration.

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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

1283.34.1 Boehringer Ingelheim Investigational Site

Neuss, Germany

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male subjects
  • overweight or obese

Exclusion criteria

  • Any relevant deviation from healthy conditions

Treatment and study plan

BI 135585 XX

Drug

one single dose

Primary outcomes

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

    Time frame: up to 4 days postdose

  2. 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 4 days postdose

Secondary outcomes

  1. AUC0-8 of BI 135585 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

    Time frame: up to 4 days postdose

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Pharmacokinetics and Pharmacodynamics of BI 135585 XX Administered as Oral Dose in Healthy Male Volunteers (Open-label, Single-dose Trial)

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 30, 2012
Registry last updated
Mar 7, 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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