At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 91 enrolled
Drug / intervention
Placebo +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 705564 (Single-blind, Partially Randomised, Placebo-controlled Parallel Group Design) and Food Effect on a Tablet Formulation of BI 705564 (Open-label, Randomised, Single-dose, Two-period, Two-sequence Crossover Design) in Healthy Male Subjects
In Brief
A Phase 1 clinical trial evaluating Placebo, BI 705564 (Test), and 1 other intervention for Healthy. Completed, enrolled 91 participants across 1 site.
Detailed Summary
Investigation of safety, tolerability, pharmacokinetics and pharmacodynamics of single rising doses of BI 705564 and of the food effect on BI 705564 in healthy male subjects
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedApr 2017
Enrollment StartApr 2017
Primary CompletionFeb 2018
TodayJul 2026
First PostedApr 21, 2017
Enrollment StartApr 27, 2017
Primary CompletionFeb 19, 2018
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 9.2 years ago
Interventions
Placebodrug
Tablet and solution formulation
BI 705564 (Test)drug
Fed state
BI 705564 (Reference)drug
Fasting state