This is a randomized, double-blind, placebo-controlled, 2-way cross-over study in healthy male and female elderly participants.
Participants will receive up to a total of 30 daily doses of study drug (15 days of daily IW-6463, only; 15 days of daily placebo, only) administered across two 15-day dosing periods (Period 1 and Period 2). The dosing periods will be separated by a 27-day washout. Participants will be randomized to a sequence of receiving IW-6463 for Period 1 and then placebo for Period 2, or vice versa.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
24
IW-6463 Tablet
Matching Placebo Tablet
Centre for Human Drug Research (CHDR)
Leiden, Netherlands
Change From Baseline in Cerebral Blood Flow (CBF) at Day 15
Change from baseline in CBF as measured by magnetic resonance imaging (MRI) and arterial spin labeling (ASL) after administration of IW-6463 vs. placebo
Time frame: Baseline, 15 days
Number of Participants With ≥1 Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 42 days
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