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

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: Healthy
• Intervention / Treatment: Drug: IW-1973; Drug: Matching Placebo Tablet

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

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

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
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	42 Days
Maximum observed plasma concentration (Cmax)	42 Days
Blood Pressure	42 days
Area under the plasma concentration time curve during a dosing interval (AUC)	42 Days
Time of maximum observed plasma concentration (Tmax)	42 Days
Heart rate	42 Days
Serum cGMP	42 Days

Collaborators and Investigators

• Sponsor: Cyclerion Therapeutics
• Investigators: Study Director: John Hanrahan, MD, Ironwood Pharmaceuticals

Study record dates

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: Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Guanylyl Cyclase C Agonists; Enzyme Activators; Praliciguat
• Other Study ID Numbers: ICP-1973-102