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San Antonio, Texas 78209

  • Healthy

Purpose:

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.


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


Study is Available At:


Original ID:

ICP-1973-102


NCT ID:

NCT02616861


Secondary ID:


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

55 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Cyclerion Therapeutics


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

54


Enrollment Type:

Actual


Overall Contact Information

Official Name:John Hanrahan, MD
Study Director
Ironwood Pharmaceuticals

Study Dates

Start Date:November 2015
Completion Date:June 2016
Completion Type:Actual
Primary Completion Date:May 2016
Primary Completion Type:Actual
Verification Date:April 2019
Last Changed Date:April 1, 2019
First Received Date:October 29, 2015

Study Outcomes

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

Study Interventions

Intervention Type:Drug
Name:IW-1973
Description:IW-1973 Tablet
Arm Name:IW-1973
Intervention Type:Drug
Name:Matching Placebo Tablet
Description:Matching placebo tablet
Arm Name:Placebo

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:Matching Placebo
Study Arm Type:Experimental
Arm Name:IW-1973
Description:1973 Escalating Doses

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Cyclerion Therapeutics

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: March 26, 2020

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