Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1060469 in Healthy Asian Male Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: BI 1060469

• Registration Number: NCT02183545
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The objective of this single rising dose study (SRD) is to investigate safety, tolerability, and pharmacokinetics of single rising doses of BI 1060469 in healthy Asian male subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-04
• Study First Submitted QC: 2014-07-04
• Study First Posted: 2014-07-08
• Status Verified: 2014-10
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Last Update Submitted: 2014-10-14
• Last Update Posted: 2014-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	given as tablet (matching placebo of BI 1060469)
BI 1060469	BI 1060469	single rising doses given as tablet

Primary Outcome Measures

Name	Time	Method
number of subjects with drug-related adverse events	up to 14 days after drug administration

Secondary Outcome Measures

Name	Time	Method
Maximum concentration of BI 1060469 (Cmax)	up to 72 hours after drug administration
Area Under the concentration-time curve of BI 1060469 over time interval from 0 interpolated to infinity ((AUC0-infinity)	up to 72 hours after drug administration
Area Under the concentration-time curve of BI 1060469 (AUC0- tz)	up to 72 hours after drug administration

Trial Locations

Locations (2)

1333.3.82001 Boehringer Ingelheim Investigational Site; 🇰🇷 Seoul, Korea, Republic of

1333.3.82002 Boehringer Ingelheim Investigational Site; 🇰🇷 Busan, Korea, Republic of