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

Condition Intervention Phase
Healthy Drug: Placebo to BI 187004 CL Drug: BI 187004 CL Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Occurrence of adverse events [ Time Frame: up to 15 days postdose ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 72
Study Start Date: April 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 187004 CL
1 single dose per subject as oral solution
Drug: BI 187004 CL
1 single dose per subject as oral solution
Placebo Comparator: Placebo to BI 187004 CL
1 single dose per subject as oral solution
Drug: Placebo to BI 187004 CL
1 single dose per subject as oral solution

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. Healthy male subjects
  2. overweight or obese

Exclusion criteria:

1. Any relevant deviation from healthy conditions

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01587417


Locations
Germany
1307.1.1 Boehringer Ingelheim Investigational Site
Neuss, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01587417     History of Changes
Other Study ID Numbers: 1307.1
2011-006183-45 ( EudraCT Number: EudraCT )
First Submitted: April 26, 2012
First Posted: April 30, 2012
Last Update Posted: November 1, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Pharmaceutical Solutions