Single Rising Oral Doses of BI 1021958 in Healthy Chinese and Japanese Male Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Test drug; Drug: matching placebo

• Registration Number: NCT01638598
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Safety,tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1021958 after single rising doses (SRD) in healthy Asian male volunteers

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-02
• Study First Submitted QC: 2012-07-11
• Study First Posted: 2012-07-12
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-31
• Last Update Posted: 2013-11-01

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 1021958 dose group 1	Test drug	subject to receive a tablet containing dose group 1 BI 1021958 single dose
BI 1021958 dose group 4	Test drug	subject to receive a tablet containing dose group 4 BI 1021958 single dose
BI 1021958 dose group 5	matching placebo	subject to receive a tablet containing dose group 5 BI 1021958 single dose
BI 1021958 dose group 1	matching placebo	subject to receive a tablet containing dose group 1 BI 1021958 single dose
BI 1021958 dose group 2	matching placebo	subject to receive a tablet containing dose group 2 BI 1021958 single dose
BI 1021958 dose group 2	Test drug	subject to receive a tablet containing dose group 2 BI 1021958 single dose
BI 1021958 dose group 3	Test drug	subject to receive a tablet containing dose group 3 BI 1021958 single dose
BI 1021958 dose group 3	matching placebo	subject to receive a tablet containing dose group 3 BI 1021958 single dose
BI 1021958 dose group 4	matching placebo	subject to receive a tablet containing dose group 4 BI 1021958 single dose
BI 1021958 dose group 5	Test drug	subject to receive a tablet containing dose group 5 BI 1021958 single dose

Primary Outcome Measures

Name	Time	Method
The number (%) of subjects with related adverse events.	up to 17 days postdose

Secondary Outcome Measures

Name	Time	Method
AUC0-12 (area under the concentration-time curve of BI 1021958 in plasma over the time interval from the time point 0 until the time point 12 h)	up to day 4 postdose
AUC0-24 (area under the concentration-time curve of BI 1021958 in plasma over the time interval from the time point 0 until the time point 24 h)	up to day 4 postdose
AUC0-tz (area under the concentration-time curve of BI 1021958 in plasma over the time interval from 0 up to the last quantifiable data point)	up to day 4 postdose
AUC0-inf (area under the concentration-time curve of BI 1021958 in plasma over the time interval from 0 extrapolated to infinity)	up to day 4 postdose
Cmax (maximum measured concentration of BI 1021958 in plasma)	up to day 4 postdose

Trial Locations

Locations (1)

1310.3.8201 Boehringer Ingelheim Investigational Site; 🇰🇷 Seoul, Korea, Republic of