Trial of IW-1701 (A Stimulator of Soluble Guanylate Cycla... | NCT02572349

Studies
Trial of IW-1701 (A Stimulator of Soluble Guanylate Cyclase (sGC)) in Healthy Volunteers

NCT02572349

Sponsor

Cyclerion Therapeutics

Status

Completed

Last Update Posted

Apr 3, 2019Actual

Enrollment

24Actual

Phase

Phase 1

Conditions

Healthy

Interventions

IW-1701
Matching Placebo

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

Oct 2015

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Oct 7, 2015

First Submission Date that Met QC Criteria

Oct 7, 2015

First Posted Date

Oct 8, 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

The objectives of the study are to assess the safety and tolerability of a range of single doses of IW-1701 when administered as oral capsules to healthy subjects, to determine the pharmacokinetic profile and pharmacodynamics effects of a range of single doses of IW-1701 when administered as oral capsules to healthy subjects.

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

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IW-1701	Experimental	Single Dose	Drug: IW-1701
Matching Placebo for IW-1701	Placebo Comparator	Single Dose	Drug: Matching Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IW-1701	Drug		IW-1701
Matching Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment of the safety and tolerability of IW-1701 in healthy subjects via adverse events	The primary objectives of this study are to assess the safety and tolerability of single ascending dosage levels of IW-1701 versus placebo in healthy subjects.	From baseline up to 8 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion:

Between 18 and 60 years old at the Screening Visit;
Women of childbearing potential must have a negative pregnancy test and must agree to use double-barrier contraception;
BMI > 18.5 and < 32.0 kg/m2 at the Screening Visit;
In overall good health with no clinically significant laboratory, ECG, or physical exam findings;
Other inclusion criteria per protocol.

Exclusion:

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

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

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