At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 83 enrolled
Drug / intervention
Placebo +3 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 of BI 1358894 in Healthy Male Subjects (Single-blind, Partially Randomised, Placebo-controlled Parallel Group Design) and Effect of Food on the Relative Bioavailability of BI 1358894 (Open-label, Randomised, Two-way Cross-over)
In Brief
A Phase 1 clinical trial evaluating Placebo, BI 1358894, and 2 other interventions for Healthy. Completed, enrolled 83 participants across 1 site.
Detailed Summary
The primary objective of this trial is to investigate the safety and tolerability of BI 1358894 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 1358894 after single dosing.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedJul 2017
Enrollment StartJul 2017
Primary CompletionFeb 2019
TodayJul 2026
First PostedJul 6, 2017
Enrollment StartJul 18, 2017
Primary CompletionFeb 18, 2019
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 9.0 years ago
Interventions
Placebodrug
Tablet
BI 1358894drug
Tablet
BI 1358894 (Test)drug
Fasting state
BI 1358894 (Reference)drug
Fed state