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

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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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ironwood Investigational Site

San Antonio, Texas, 78209, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion:

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;
Other inclusion criteria per protocol.

Exclusion:

History of any clinically-significant medical condition;
Other exclusion criteria per protocol.

Treatment and study plan

IW-1701

Drug

Matching Placebo

Drug

Primary outcomes

Assessment of the safety and tolerability of IW-1701 in healthy subjects via adverse events

Time frame: From baseline up to 8 days

The primary objectives of this study are to assess the safety and tolerability of single ascending dosage levels of IW-1701 versus placebo in healthy subjects.

Sponsors and collaborators

Lead sponsor

Cyclerion Therapeutics

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IW-1701 Administered Orally as Single Doses to Healthy Subjects

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Oct 8, 2015
Registry last updated: Apr 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed