At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 60 enrolled
Drug / intervention
BI 705564 +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 Multiple Rising Oral Doses of BI 705564 (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 705564, Placebo, and 1 other intervention for Healthy. Completed, enrolled 60 participants across 1 site.
Detailed Summary
The primary objective of this trial is to investigate safety and tolerability of BI 705564 in healthy male subjects, following oral administration of multiple rising doses. Secondary objectives are the exploration of the pharmacokinetics, including dose proportionality and investigation of linearity.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedOct 2017
Enrollment StartNov 2017
Primary CompletionNov 2018
TodayJul 2026
First PostedOct 30, 2017
Enrollment StartNov 17, 2017
Primary CompletionNov 26, 2018
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 8.7 years ago
Interventions
BI 705564drug
Film-coated tablet
Placebodrug
Film-coated tablet
Midazolamdrug
Solution for injection