At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 56 enrolled
Drug / intervention
BI 1569912 +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 and Pharmacokinetics of Single Rising Oral Doses and Multiple Oral Doses of BI 1569912 in Healthy Male Japanese Subjects (Single-blind, Partially Randomized Within Dose Groups, Placebo-controlled, Parallel-group Design)
In Brief
A Phase 1 clinical trial evaluating BI 1569912 and Placebo for Healthy. Completed, enrolled 56 participants across 1 site.
Detailed Summary
The main objectives of this trial are to investigate safety and tolerability of BI 1569912 in healthy male Japanese subjects following oral administration of single rising doses and multiple doses. Secondary objective is the exploration of pharmacokinetics (PK) of BI 1569912.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesJapan
Collaborators--
Timeline
Phase 1CompletedFinished
20222023202420252026
First PostedJul 2021
Enrollment StartAug 2021
Primary CompletionOct 2023
TodayJul 2026
First PostedJul 12, 2021
Enrollment StartAug 5, 2021
Primary CompletionOct 30, 2023
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 5.0 years ago
Interventions
BI 1569912drug
BI 1569912
Placebodrug
Placebo