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

NCT02383888 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2026-03-30

Study results available
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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.

Conditions

  • Healthy

Interventions

DRUG

BI 425809

Single dose administered orally as tablets with 240 mL water after an overnight fast of at least 10 hours

DRUG

Placebo

Single dose matching BI 425809 administered as tablets orally with 240 mL of water after an overnight fast of at least 10 hours.

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-11
Primary Completion
2015-08-06
Completion
2015-08-06

Countries

  • South Korea

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02383888 on ClinicalTrials.gov