At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 16 enrolled
Drug / intervention
BI 1015550 6 mg +1 moredrug
Likely dose
BI 1015550 6 mgfrom 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 of BI 1015550 in Healthy Japanese Male Subjects (Double-blind, Randomised, Placebo-controlled, Parallel Group Design)
In Brief
A Phase 1 clinical trial evaluating BI 1015550 6 mg and Placebo for Healthy. Completed, enrolled 16 participants across 1 site.
Detailed Summary
The primary objective of this trial is to investigate the safety and tolerability of BI 1015550 in healthy male subjects following oral administration of single rising doses. Secondary objectives are the exploration of the pharmacokinetics (PK) including dose proportionality of BI 1015550 after single dosing.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesJapan
Collaborators--
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
First PostedMay 2018
Enrollment StartJun 2018
Primary CompletionAug 2018
TodayJul 2026
First PostedMay 31, 2018
Enrollment StartJun 4, 2018
Primary CompletionAug 24, 2018
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 8.1 years ago
Interventions
BI 1015550 6 mgdrug
Single rising oral dose
Placebodrug
Single rising oral dose