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

April 1, 2019 updated by: Cyclerion Therapeutics

A 2-stage Phase 1 Study of Safety, Tolerability, PK, and PD of IW-1973 Tablet in Healthy Volunteers in an Open-label, Single-dose Stage, and a Randomized, Double Blind, Placebo-controlled, Multiple-ascending-dose Stage

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78209
        • Ironwood Investigator

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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
  • Other inclusion criteria per protocol

Exclusion Criteria:

  • History of any clinically significant medical condition
  • Other exclusion criteria per protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Matching Placebo
Drug: Matching Placebo Tablet
Matching placebo tablet
Experimental: IW-1973
1973 Escalating Doses
Drug: IW-1973
IW-1973 Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Treatment Emergent Adverse Events
Time Frame: 42 Days
42 Days
Maximum observed plasma concentration (Cmax)
Time Frame: 42 Days
42 Days
Blood Pressure
Time Frame: 42 days
42 days
Area under the plasma concentration time curve during a dosing interval (AUC)
Time Frame: 42 Days
42 Days
Time of maximum observed plasma concentration (Tmax)
Time Frame: 42 Days
42 Days
Heart rate
Time Frame: 42 Days
42 Days
Serum cGMP
Time Frame: 42 Days
42 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cyclerion Therapeutics

Investigators

  • Study Director: John Hanrahan, MD, Ironwood Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

October 29, 2015

First Submitted That Met QC Criteria

November 27, 2015

First Posted (Estimate)

November 30, 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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICP-1973-102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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