Single Rising Dose Study of BI 135585 XX in Health Asian Male Volunteers.

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 135585 XX; Drug: Matching placebo

• Registration Number: NCT01291732
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The Aim of the study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics in Asian healthy males administered a single dose of BI 135585.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-07
• Study First Submitted QC: 2011-02-07
• Study First Posted: 2011-02-08
• Primary Completion: 2011-04
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-31
• Last Update Posted: 2013-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 135585 XX	BI 135585 XX	single dose of BI 135585
matching placebo	Matching placebo	single dose of matching placebo

Primary Outcome Measures

Name	Time	Method
Changes in Vital signs (blood pressure (BP), pulse rate (PR), respiratory rate(RR))	up to 21 days
Changes in 12-lead ECG (electrocardiogram)	up to 21 days
Occurrence of Adverse events	up to 21 days
Changes in Clinical laboratory tests (haematology, clinical chemistry and urinalysis)	up to 21 days

Secondary Outcome Measures

Name	Time	Method
Tmax (maximum measured concentration of the analyte in plasma)	10 days
AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)	10 days
Cmax (maximum measured concentration of the analyte in plasma)	10 days

Trial Locations

Locations (1)

1283.5.82001 Boehringer Ingelheim Investigational Site; 🇰🇷 Seoul, Korea, Republic of