At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 68 enrolled
Drug / intervention
BI 894416 +2 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 Single Rising Oral Doses of BI 894416 in Healthy Male Subjects (Single-blind, Partially Randomised, Placebo-controlled Parallel Group Design)
In Brief
A Phase 1 clinical trial evaluating BI 894416 and Placebo for Healthy. Completed, enrolled 68 participants across 1 site.
Detailed Summary
This first-in man trial is designed to investigate the safety and tolerability of BI 894416 in healthy male subjects following oral administration of single rising doses. Pharmacokinetics (PK) including dose proportionality after single dosing of BI 894416 as oral solution will be explored, the investigation of PK of BI 894416 as tablet formulation and the exploration of relative bioavailability of BI 894416 as tablet formulation compared to oral solution.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedOct 2017
Enrollment StartNov 2017
Primary CompletionSep 2018
TodayJul 2026
First PostedOct 20, 2017
Enrollment StartNov 2, 2017
Primary CompletionSep 10, 2018
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 8.7 years ago
Interventions
BI 894416drug
powder for oral solution
Placebodrug
Oral solution
BI 894416drug
Tablet