At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 61 enrolled
Drug / intervention
Placebo matching BI 409306 25 mg +3 moredrug
Likely dose
Placebo matching BI 409306 25 mgfrom 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, Parallel-group, Double-blind Study of Systemic and Ocular Safety and Pharmacokinetics of BI 409306 in Patients With Schizophrenia, Alzheimer's Disease, and Age-comparable Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating Placebo matching BI 409306 25 mg, Placebo matching BI 409306 50 mg, and 2 other interventions for Schizophrenia and Alzheimer Disease. Completed, enrolled 61 participants across 3 sites.
Detailed Summary
Single site, parallel-group, double-blind trial of low or high dose of BI 409306 to evaluate the ocular and systemic safety and pharmacokinetics during 14 day treatment period in patients with schizophrenia, Alzheimer's disease, or age comparable healthy volunteers.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia, Alzheimer Disease
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 2015
Enrollment StartApr 2015
Primary CompletionAug 2017
Study CompletionAug 2017
TodayJul 2026
First PostedMar 19, 2015
Enrollment StartApr 15, 2015
Primary CompletionAug 3, 2017
Study CompletionAug 10, 2017
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 11.3 years ago
Interventions
Placebo matching BI 409306 25 mgdrug
Film-coated tablet
Placebo matching BI 409306 50 mgdrug
Film-coated tablet
BI 409306 25 mgdrug
Film-coated tablet
BI 409306 50 mgdrug
Film-coated tablet