At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 20 enrolled
Drug / intervention
BI 409306 +1 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.
Randomised, Double-blind, Placebo-controlled Parallel-group Proof of Mechanism Study to Assess the Pharmacokinetics and to Evaluate the Pharmacodynamic Effect of Different Single Oral Doses of BI 409306 in Healthy Male Volunteers
In Brief
A Phase 1 clinical trial evaluating BI 409306 and Placebo for Healthy. Completed, enrolled 20 participants across 1 site.
Detailed Summary
Due to the exploratory nature of this trial, there is no primary objective in a confirmatory sense. The study aims \- to evaluate the effect of different doses of BI 409306 on biomarker and to assess the exposure of BI 409306
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesBelgium
Collaborators--
Timeline
Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2011
First PostedDec 2011
Primary CompletionFeb 2012
Study CompletionFeb 2012
TodayJul 2026
First PostedDec 16, 2011
Enrollment StartDec 1, 2011
Primary CompletionFeb 1, 2012
Study CompletionFeb 21, 2012
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 14.5 years ago
Interventions
BI 409306drug
Film-coated tablet
Placebodrug
Film-coated tablet