IW-6463 Safety Study in Healthy Elderly Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-06

Study Completion Date

2020-05-22

Brief Summary

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

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Detailed Description

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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.

Conditions

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Other

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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IW-6463

IW-6463 tablets administered orally

Group Type EXPERIMENTAL

IW-6463

Intervention Type DRUG

IW-6463 Tablet

Placebo

Matching placebo tablets administered orally

Group Type PLACEBO_COMPARATOR

Matching Placebo

Intervention Type DRUG

Matching Placebo Tablet

Interventions

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IW-6463

IW-6463 Tablet

Intervention Type DRUG

Matching Placebo

Matching Placebo Tablet

Intervention Type DRUG

Other Intervention Names

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CY6463 zagociguat

Eligibility Criteria

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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