IW-6463 Safety Study in Healthy Elderly Subjects

Phase 1

Terminated

• Conditions: Other
• Interventions: Drug: IW-6463; Drug: Matching Placebo

• Registration Number: NCT04240158
• Lead Sponsor: Tisento Therapeutics

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.

Study Timeline

• Study Start: 2020-01-06
• Study First Submitted: 2020-01-21
• Study First Submitted QC: 2020-01-21
• Study First Posted: 2020-01-27
• Primary Completion: 2020-05-22
• Study Completion: 2020-05-22
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

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 exclusion criteria per protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
IW-6463	IW-6463	IW-6463 tablets administered orally
Placebo	Matching Placebo	Matching placebo tablets administered orally

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Centre for Human Drug Research (CHDR); 🇳🇱 Leiden, Netherlands