At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 48 enrolled
Drug / intervention
BI 1467335 +1 moredrug
Likely dose
Not stated in 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.
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 1467335 in Healthy Japanese Male Volunteers With Multiple Oral Doses at the Highest Dose in Caucasian for Comparison (Randomised, Double-blind, Placebo-controlled Trial)
In Brief
A Phase 1 clinical trial evaluating BI 1467335 and Placebo for Healthy. Completed, enrolled 48 participants across 2 sites.
Detailed Summary
The primary objective of the current study is to investigate the safety and tolerability of BI 1467335 in healthy Japanese male subjects following oral administration of multiple rising doses The Caucasian group will receive higher dose only. A secondary objective is the exploration of the pharmacokinetics and pharmacodynamics of BI 1467335 in healthy Japanese and Caucasian male subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesJapan
Collaborators--
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedMay 2017
Enrollment StartJun 2017
Primary CompletionDec 2017
TodayJul 2026
First PostedMay 18, 2017
Enrollment StartJun 7, 2017
Primary CompletionDec 16, 2017
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 9.1 years ago
Interventions
BI 1467335drug
Duration - 28 days
Placebodrug
Duration - 28 days