IW-6463 Safety Study in Healthy Elderly Subjects

Tisento Therapeutics

Status and phase: Terminated; Phase 1

Conditions: Other

Treatments: Drug: IW-6463; Drug: Matching Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04240158

C6463-102

CY6463 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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24 participants in 2 patient groups, including a placebo group

IW-6463

Experimental group

Description:

IW-6463 tablets administered orally

Treatment:

Drug: IW-6463

Placebo

Placebo Comparator group

Description:

Matching placebo tablets administered orally

Treatment:

Drug: Matching Placebo