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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 135585 XX

• Registration Number: NCT01652742
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-26
• Study First Submitted QC: 2012-07-26
• Study First Posted: 2012-07-30
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-06
• Last Update Posted: 2013-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BI 135585 XX	BI 135585 XX	one single dose

Primary Outcome Measures

Name	Time	Method
Cmax (maximum measured concentration of the analyte in plasma)	up to 4 days 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)	up to 4 days postdose

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

1283.34.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Neuss, Germany