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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Matching Placebo; Drug: IW-1701

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78209
      • Ironwood Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IW-1701; Single Dose	Drug: IW-1701
Placebo Comparator: Matching Placebo for IW-1701; Single Dose	Drug: Matching Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the safety and tolerability of IW-1701 in healthy subjects via adverse events	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.	From baseline up to 8 days

Collaborators and Investigators

• Sponsor: Cyclerion Therapeutics

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: October 7, 2015
• First Submitted That Met QC Criteria: October 7, 2015
• First Posted (Estimate): October 8, 2015

Study Record Updates

• Last Update Posted (Actual): April 3, 2019
• Last Update Submitted That Met QC Criteria: April 1, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Healthy Subjects
• Other Study ID Numbers: ICP-1701-101