At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 49 enrolled

Drug / intervention

BI 425809 +1 moredrug

Likely dose

BI 425809 240 mLfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02383888

NCT02383888Phase 1Completed

Compare CT.gov

Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 425809 in Healthy Japanese and Chinese Male Subjects (Randomized, Double-blind, Placebo-controlled Design Within Dose Groups)

Boehringer Ingelheim·interventional·Posted Mar 10, 2015·Updated Mar 30, 2026

In Brief

A Phase 1 clinical trial evaluating BI 425809 and Placebo for Healthy. Completed, enrolled 49 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHealthy

CountriesSouth Korea

Collaborators--

Timeline

Phase 1CompletedFinished

201520162017201820192020202120222023202420252026

First PostedMar 2015

Enrollment StartMay 2015

Primary CompletionAug 2015

TodayJul 2026

First PostedMar 10, 2015

Enrollment StartMay 11, 2015

Primary CompletionAug 6, 2015

TodayJul 2, 2026

Enrollment to primary: 3 monthsPosted 11.3 years ago

Interventions

BI 425809drug

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

Placebodrug

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