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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02616861
Recruitment Status : Completed
First Posted : November 30, 2015
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
Cyclerion Therapeutics

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

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Study Type : Interventional  (Clinical Trial)
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 : November 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : June 2016

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




Primary Outcome Measures :
  1. Treatment Emergent Adverse Events [ Time Frame: 42 Days ]
  2. Maximum observed plasma concentration (Cmax) [ Time Frame: 42 Days ]
  3. Blood Pressure [ Time Frame: 42 days ]
  4. Area under the plasma concentration time curve during a dosing interval (AUC) [ Time Frame: 42 Days ]
  5. Time of maximum observed plasma concentration (Tmax) [ Time Frame: 42 Days ]
  6. Heart rate [ Time Frame: 42 Days ]
  7. Serum cGMP [ Time Frame: 42 Days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02616861


Locations
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United States, Texas
Ironwood Investigator
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Cyclerion Therapeutics
Investigators
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Study Director: John Hanrahan, MD Ironwood Pharmaceuticals

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Responsible Party: Cyclerion Therapeutics
ClinicalTrials.gov Identifier: NCT02616861    
Other Study ID Numbers: ICP-1973-102
First Posted: November 30, 2015    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019