IW-6463 Safety Study in Healthy Elderly Subjects

Other Clinical Trial

Official title:

Evaluating the Safety, Tolerability, and Pharmacodynamic Properties of IW-6463 in Healthy Elderly Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04240158
• Other study ID #: C6463-102
• Secondary ID: CY6463
• Status: Terminated
• Phase: Phase 1
• Start date: January 6, 2020
• Est. completion date: May 22, 2020

Study information

• Verified date: October 2023
• Source: Tisento Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, double-blind, placebo-controlled, 2-way cross-over study in healthy male and female elderly participants.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: May 22, 2020
• Est. primary completion date: May 22, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Other

Intervention

Drug:
• IW-6463
IW-6463 Tablet
• Matching Placebo
Matching Placebo Tablet

Locations

Country	Name	City	State
Netherlands	Centre for Human Drug Research (CHDR)	Leiden

Sponsors (1)

Lead Sponsor	Collaborator
Tisento Therapeutics

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline, 15 days
Primary	Number of Participants With =1 Treatment-Emergent Adverse Events (TEAEs)		Up to 42 days