This Study Tests BI 685509 in Healthy Chinese and Japanese Men; the Study Tests How Different Doses of BI 685509 Are Taken up in the Body and How Well They Are Tolerated

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: BI 685509

• Registration Number: NCT03259464
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The primary objective of this trial is to investigate the safety and tolerability of BI 685509 in healthy male subjects following oral administration of multiple rising doses.

Secondary objectives are the exploration of the pharmacokinetics (PK) and pharmacodynamics (PD) of BI 685509 in healthy Chinese and Japanese subjects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-22
• Study First Submitted QC: 2017-08-22
• Study First Posted: 2017-08-23
• Study Start: 2017-09-04
• Primary Completion: 2018-05-26
• Study Completion: 2018-05-26
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-03
• Last Update Posted: 2018-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 72

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Chinese \& Japanese subjects
BI 685509	BI 685509	Chinese \& Japanese subjects

Primary Outcome Measures

Name	Time	Method
Number [N (%)] of subjects with drug-related Adverse Events (AEs)	up to day 35

Secondary Outcome Measures

Name	Time	Method
After the first dose:AUC0-24 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 h)	up to 24 hours
After the first dose:Cmax (maximum measured concentration of the analyte in plasma)	up to 72 hours
After the drug administration on Day 10 and Day 17 of DGs 1-2: AUCtau,ss (area under the concentration-time curve of the analyte in plasma over the dosing interval tau at steady state) [AUCtau,ss will be AUC0-12,ss for b.i.d. and AUC0-24,ss for q.d.]	Dose Group (DG) 1: up to 240 hours & up to 408 hours DG2: up to 240 hours & up to 396 hours
After the drug administration on Day 10 and Day 17 of DGs 1-2: Cmax,ss (maximum measured concentration of the analyte in plasma at steady state)	Dose Group (DG) 1: up to 240 hours & up to 408 hours DG2: up to 240 hours & up to 396 hours

Trial Locations

Locations (2)

SOUSEIKAI Sumida Hospital; 🇯🇵 Tokyo, Sumida-ku, Japan

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of