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

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01652742
• Collaborator: (none)
• Enrollment: 9
• Location: 1
• Arm: 1
• Duration (Months): 2
• Patients Per Site Per Month: 4.4

Study Details

Study Description

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 Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: N/A
• 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: Jul 1, 2012
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Cmax (maximum measured concentration of the analyte in plasma) [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) [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) [up to 4 days postdose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion criteria:

1. Healthy male subjects

2. overweight or obese

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	1283.34.1 Boehringer Ingelheim Investigational Site	Neuss		Germany

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

• Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT01652742
• Other Study ID Numbers: 1283.34; 2012-000844-85
• First Posted: Jul 30, 2012
• Last Update Posted: Mar 7, 2013
• Last Verified: Mar 1, 2013

Study Results

No Results Posted as of Mar 7, 2013