Single Rising Dose Trial of BI 425809 for Healthy Japanese and Chinese Male Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: BI 425809

• Registration Number: NCT02383888
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To investigate the safety, tolerability and pharmacokinetics of BI 425809 tablets in healthy Chinese and Japanese male subjects following the administration of single rising oral doses and further to explore the pharmacokinetics (PK) including dose proportionality of BI 425809 after single dosing of product.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-06
• Study First Submitted QC: 2015-03-09
• Study First Posted: 2015-03-10
• Study Start: 2015-05
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-12
• Last Update Posted: 2015-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 49

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
Matching placebo for each dose groups	Placebo	-
BI 425809 Active dose group 1	BI 425809	-
BI 425809 Active dose group 2	BI 425809	-
Bi 425809 Active dose group 3	BI 425809	-

Primary Outcome Measures

Name	Time	Method
the number of subjects with drug-related Adverse Events	up to 18 days post dosing

Secondary Outcome Measures

Name	Time	Method
maximum measured concentration of the analyte in plasma	up to 9 days post doing
area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable plasma concentration	up to 9 days post doing
time from dosing to the maximum concentration of the analyte in plasma	up to 9 days post doing
area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity	up to 9 days post doing
terminal half-life of the analyte in plasma	up to 9 days post doing

Trial Locations

Locations (1)

1346.4.82001 Boehringer Ingelheim Investigational Site; 🇰🇷 Busan, Korea, Republic of