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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01652742
First received: July 26, 2012
Last updated: March 6, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention Phase
Healthy
Drug: BI 135585 XX
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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)

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 4 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 4 days postdose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: July 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 135585 XX
one single dose
Drug: BI 135585 XX
one single dose

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01652742

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

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01652742     History of Changes
Other Study ID Numbers: 1283.34, 2012-000844-85
Study First Received: July 26, 2012
Last Updated: March 6, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on April 17, 2014