Study of Systemic and Ocular Safety and Pharmacokinetics of BI 409306 in Patients With Schizophrenia, Alzheimer's Disease, and Healthy Volunteers
NCT02392468 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 61
Last updated 2024-04-19
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.
Conditions
- Schizophrenia
- Alzheimer Disease
Interventions
- DRUG
-
Placebo matching BI 409306 25 mg
Film-coated tablet
- DRUG
-
Placebo matching BI 409306 50 mg
Film-coated tablet
- DRUG
-
BI 409306 25 mg
Film-coated tablet
- DRUG
-
BI 409306 50 mg
Film-coated tablet
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Boehringer Ingelheim · Boehringer Ingelheim
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-04-15
- Primary Completion
- 2017-08-03
- Completion
- 2017-08-10
Countries
- United States
Study Locations
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