At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 50 enrolled
Drug / intervention
BI 1358894 +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, and Pharmacokinetics of Multiple Rising Oral Doses of BI 1358894 (Double-blind, Randomised, Placebo-controlled, Parallel-group Design) and Evaluation of Midazolam Interaction (Nested, Open, Fixed-sequence, Intra-individual Comparison) in Healthy Male Subjects
In Brief
A Phase 1 clinical trial evaluating BI 1358894, Placebo, and 1 other intervention for Healthy. Completed, enrolled 50 participants across 1 site.
Detailed Summary
The primary objective of the trial is to investigate the safety and tolerability of BI 1358894 in healthy male subjects following oral administration of multiple rising doses over 14 days.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
First PostedNov 2018
Enrollment StartDec 2018
Primary CompletionJul 2019
TodayJul 2026
First PostedNov 27, 2018
Enrollment StartDec 18, 2018
Primary CompletionJul 22, 2019
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 7.6 years ago
Interventions
BI 1358894drug
Film-coated tablet
Placebodrug
Film-coated tablet
Midazolamdrug
Solution for injection