Trial of IW-1973 (A Stimulator of Soluble Guanylate Cycla... | NCT02616861

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

NCT02616861

Sponsor

Cyclerion Therapeutics

Status

Completed

Last Update Posted

Apr 3, 2019Actual

Enrollment

54Actual

Phase

Phase 1

Conditions

Healthy

Interventions

IW-1973
Matching Placebo Tablet

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2015

Primary Completion Date

May 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

Oct 29, 2015

First Submission Date that Met QC Criteria

Nov 27, 2015

First Posted Date

Nov 30, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 1, 2019

Last Update Posted Date

Apr 3, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

54Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IW-1973	Experimental	1973 Escalating Doses	Drug: IW-1973
Placebo	Placebo Comparator	Matching Placebo	Drug: Matching Placebo Tablet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IW-1973	Drug	IW-1973 Tablet	IW-1973
Matching Placebo Tablet

Outcomes Module

Primary Outcomes

Measure	Description	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John Hanrahan, MD	Ironwood Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ironwood Investigator		San Antonio	Texas	78209	United States

Intervention Browse Module

MeSH Terms

ID	Term
C000631485	praliciguat

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided