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

• Sponsor: Cyclerion Therapeutics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02616861
• Collaborator: (none)
• Enrollment: 54
• Location: 1
• Arms: 2
• Duration (Months): 7
• Patients Per Site Per Month: 7.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: IW-1973; Drug: Matching Placebo Tablet	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 54 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Nov 1, 2015
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Treatment Emergent Adverse Events [42 Days]

2. Maximum observed plasma concentration (Cmax) [42 Days]

3. Blood Pressure [42 days]

4. Area under the plasma concentration time curve during a dosing interval (AUC) [42 Days]

5. Time of maximum observed plasma concentration (Tmax) [42 Days]

6. Heart rate [42 Days]

7. Serum cGMP [42 Days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ironwood Investigator	San Antonio	Texas	United States	78209

Sponsors and Collaborators

• Cyclerion Therapeutics

Investigators

• Study Director: John Hanrahan, MD, Ironwood Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cyclerion Therapeutics
• ClinicalTrials.gov Identifier: NCT02616861
• Other Study ID Numbers: ICP-1973-102
• First Posted: Nov 30, 2015
• Last Update Posted: Apr 3, 2019
• Last Verified: Apr 1, 2019

• Additional relevant MeSH terms: Praliciguat

Study Results

No Results Posted as of Apr 3, 2019