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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 20, 2014