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

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ClinicalTrials.gov Identifier: NCT01652742
Recruitment Status : Completed
First Posted : July 30, 2012
Last Update Posted : March 7, 2013
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Healthy Drug: BI 135585 XX Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics and Pharmacodynamics of BI 135585 XX Administered as Oral Dose in Healthy Male Volunteers (Open-label, Single-dose Trial)
Study Start Date : July 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Arm Intervention/treatment
Experimental: BI 135585 XX
one single dose
Drug: BI 135585 XX
one single dose



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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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


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): NCT01652742


Locations
Germany
1283.34.1 Boehringer Ingelheim Investigational Site
Neuss, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01652742     History of Changes
Other Study ID Numbers: 1283.34
2012-000844-85 ( EudraCT Number: EudraCT )
First Posted: July 30, 2012    Key Record Dates
Last Update Posted: March 7, 2013
Last Verified: March 2013