A Trial of IW-1701, A Stimulator of Soluble Guanylate Cyclase (sGC), in Healthy 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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2016-11-30

Brief Summary

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The objectives of this study are:

Stage 1: To assess the safety, tolerability, pharmacokinetic (PK) profile and pharmacodynamic (PD) effects of a range of doses of IW-1701 tablets administered orally to healthy subjects over 7 days of repeated dosing

Stage 2: To assess the safety, tolerability, PK profile and PD effects of IW-1701 tablets administered orally to healthy subjects, in fed and fasted states, in an open-label, single-dose, 2-period, 2-sequence crossover study.

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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-1701

IW-1701 tablets administered orally in multiple ascending dose.

Group Type EXPERIMENTAL

IW-1701

Intervention Type DRUG

IW-1701 Tablet

Placebo

Matching placebo tablets administered orally.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching Placebo Tablet

Interventions

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IW-1701

IW-1701 Tablet

Intervention Type DRUG

Placebo

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 at the time of check-in and must agree to use double-barrier contraception throughout the duration of the study
* Subject is in good health and has no clinically significant findings on a physical examination