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OpenTrials
Completed

NCT Number: NCT01587417

Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 187004 CL

To investigate safety, tolerability, pharmacokinetics including dose proportionality, and pharmacodynamics of BI 187004 CL within a predefined dose range

Completed

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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

1307.1.1 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

Placebo to BI 187004 CL

Drug

1 single dose per subject as oral solution

BI 187004 CL

Drug

1 single dose per subject as oral solution

Primary outcomes

  1. Occurrence of adverse events

    Time frame: up to 15 days postdose

Secondary outcomes

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

    Time frame: up to 96 hours postdose

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

    Time frame: up to 96 hours postdose

  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: up to 96 hours postdose

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Randomised, Double-blind, Placebo-controlled Trial in Healthy Volunteers to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of 2.5 mg to 360 mg of BI 187004 CL

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 30, 2012
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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