Trial of IW-1973 (A Stimulator of Soluble Guanylate Cyclase (sGC)) in Healthy Volunteers

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-06-30

Brief Summary

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Stage 1: To assess the safety, tolerability, pharmacokinetic (PK) profile, and pharmacodynamic (PD) effects of the IW-1973 Tablet administered orally to healthy volunteers, in fed and fasted states, in a single-dose crossover study.

Stage 2: To assess the safety, tolerability, PK profile, and PD effects of a range of doses of IW-1973 Tablet administered orally to healthy subjects in a 21-day, multiple ascending-dose study with optional up-titration of dose level within cohort.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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IW-1973

1973 Escalating Doses

Group Type EXPERIMENTAL

IW-1973

Intervention Type DRUG

IW-1973 Tablet

Placebo

Matching Placebo

Group Type PLACEBO_COMPARATOR

Matching Placebo Tablet

Intervention Type DRUG

Matching placebo tablet

Interventions

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IW-1973

IW-1973 Tablet

Intervention Type DRUG

Matching Placebo Tablet

Matching placebo tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subject is an ambulatory male or female between 18 and 55 years old at the Screening Visit
* Subject's body mass index score is \> 18.5 and \< 30.0 kg/m2 at the Screening Visit
* Women of childbearing potential must have a negative pregnancy test and must agree to use double-barrier contraception
* Subject is in good health and has no clinically significant findings on a physical examination