At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 40 enrolled
Drug / intervention
Placebo +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.
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 409306 Film-coated Tablets Given Orally q.d. for 14 Days in Patients With Schizophrenia (Randomized, Parallel-group, Double-blind, Placebo-controlled Study)
In Brief
A Phase 1 clinical trial evaluating Placebo and BI 409306 for Schizophrenia. Completed, enrolled 40 participants across 1 site.
Detailed Summary
The primary objective of the current study is to investigate the safety and tolerability of BI 409306 in schizophrenic patients following oral administration of multiple low, medium, and high doses over 14 days. A secondary objective is the exploration of the pharmacokinetics and pharmacodynamics of BI 409306 in schizophrenic patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJun 2013
First PostedJul 2013
Primary CompletionDec 2013
TodayJul 2026
First PostedJul 4, 2013
Enrollment StartJun 28, 2013
Primary CompletionDec 5, 2013
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 13.0 years ago
Interventions
Placebodrug
matching placebo
BI 409306drug
BI 409306