We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01587417
First Posted: April 30, 2012
Last Update Posted: November 1, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
April 26, 2012
April 30, 2012
November 1, 2013
April 2012
October 2012   (Final data collection date for primary outcome measure)
Occurrence of adverse events [ Time Frame: up to 15 days postdose ]
Same as current
Complete list of historical versions of study NCT01587417 on ClinicalTrials.gov Archive Site
  • Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 96 hours postdose ]
  • 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 ]
  • 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 ]
  • Clinical laboratory parameters (haematology, coagulation, enzymes, substrates, electrolytes, hormones, and urinalysis) [ Time Frame: up to 15 days postdose ]
  • Vital signs (blood pressure, pulse rate) [ Time Frame: up to 15 days postdose ]
  • 12-lead electrocardiogram with special attention to QTc prolongation [ Time Frame: up to 15 days postdose ]
  • Physical examination (occurence of clinically relevant findings) [ Time Frame: up to 15 days postdose ]
  • Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 5 days postdose ]
  • 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 5 days postdose ]
  • 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 5 days postdose ]
Not Provided
Not Provided
 
Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 187004 CL
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
To investigate safety, tolerability, pharmacokinetics including dose proportionality, and pharmacodynamics of BI 187004 CL within a predefined dose range
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Healthy
  • Drug: Placebo to BI 187004 CL
    1 single dose per subject as oral solution
  • Drug: BI 187004 CL
    1 single dose per subject as oral solution
  • Experimental: BI 187004 CL
    1 single dose per subject as oral solution
    Intervention: Drug: BI 187004 CL
  • Placebo Comparator: Placebo to BI 187004 CL
    1 single dose per subject as oral solution
    Intervention: Drug: Placebo to BI 187004 CL
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
October 2012
October 2012   (Final data collection date for primary outcome measure)

Inclusion criteria:

  1. Healthy male subjects
  2. overweight or obese

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Sexes Eligible for Study: Male
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01587417
1307.1
2011-006183-45 ( EudraCT Number: EudraCT )
Not Provided
Not Provided
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP