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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01587417
First received: April 26, 2012
Last updated: October 31, 2013
Last verified: October 2013

April 26, 2012
October 31, 2013
April 2012
October 2012   (final data collection date for primary outcome measure)
Occurrence of adverse events [ Time Frame: up to 15 days postdose ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Clinical laboratory parameters (haematology, coagulation, enzymes, substrates, electrolytes, hormones, and urinalysis) [ Time Frame: up to 15 days postdose ] [ Designated as safety issue: No ]
  • Vital signs (blood pressure, pulse rate) [ Time Frame: up to 15 days postdose ] [ Designated as safety issue: No ]
  • 12-lead electrocardiogram with special attention to QTc prolongation [ Time Frame: up to 15 days postdose ] [ Designated as safety issue: No ]
  • Physical examination (occurence of clinically relevant findings) [ Time Frame: up to 15 days postdose ] [ Designated as safety issue: No ]
  • Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 5 days postdose ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01587417
1307.1, 2011-006183-45
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