A Phase 1b/2, Randomized, Double-blind, Placebo-Controlled, Multiple Oral Dose Escalation Study to Assess Safety, Tolerability and Pharmacokinetics of ITI-007 in Healthy Geriatric Volunteers and in Geriatric Patients with Dementia
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
35
Unnamed facility
Glendale, California, United States
Number of participants with adverse events
Vital signs, 12-lead ECGs, clinical laboratory testing, and adverse events will be assessed.
Time frame: up to 7 days
Area under the concentration-time curve (AUC)
Time frame: pre-dose and multiple collection points up to 72 h after the last dose
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Placebo for Part 2