Other
Conditions
Brief summary
This is a randomized, double-blind, placebo-controlled, 2-way cross-over study in healthy male and female elderly participants.
Detailed description
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.
Interventions
DRUGIW-6463
IW-6463 Tablet
DRUGMatching Placebo
Matching Placebo Tablet
Sponsors
Tisento Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subject is an ambulatory adult at least 65 years old at the screening visit * Subject is in good health and has no clinically significant findings on physical examination * Female participants must be postmenopausal. A postmenopausal state is defined as no menses for ≥12 consecutive months without an alternative medical cause. A high follicle-stimulating hormone (FSH) level at screening (\>40 IU/L or mIU/mL) in the postmenopausal range may be used to confirm a postmenopausal state. * Male participants who have not been surgically sterilized by vasectomy (conducted ≥60 days before the Screening Visit or confirmed via sperm analysis) must agree contraceptive use per protocol * Men must also agree to not donate sperm throughout the study and for 3 months after the final dose of study drug * Other inclusion criteria per protocol
Exclusion criteria
* Any active or unstable clinically significant medical condition * Other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Cerebral Blood Flow (CBF) at Day 15 | Baseline, 15 days | Change from baseline in CBF as measured by magnetic resonance imaging (MRI) and arterial spin labeling (ASL) after administration of IW-6463 vs. placebo |
| Number of Participants With ≥1 Treatment-Emergent Adverse Events (TEAEs) | Up to 42 days | — |
Countries
Netherlands
Outcome results
None listed