Trial of IW-1701 (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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2015-12-31

Brief Summary

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The objectives of the study are to assess the safety and tolerability of a range of single doses of IW-1701 when administered as oral capsules to healthy subjects, to determine the pharmacokinetic profile and pharmacodynamics effects of a range of single doses of IW-1701 when administered as oral capsules to healthy subjects.

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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

Single Dose

Group Type EXPERIMENTAL

IW-1701

Intervention Type DRUG

Matching Placebo for IW-1701

Single Dose

Group Type PLACEBO_COMPARATOR

Matching Placebo

Intervention Type DRUG

Interventions

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IW-1701

Intervention Type DRUG

Matching Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Between 18 and 60 years old at the Screening Visit;
* Women of childbearing potential must have a negative pregnancy test and must agree to use double-barrier contraception;
* BMI \> 18.5 and \< 32.0 kg/m2 at the Screening Visit;
* In overall good health with no clinically significant laboratory, ECG, or physical exam findings;

Exclusion:

* History of any clinically-significant medical condition;

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes