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

Sponsor

Cyclerion Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT02572349

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: IW-1701 Drug: Matching Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-blind, Placebo-controlled, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IW-1701 Administered Orally as Single Doses to Healthy Subjects

Study Start Date :

Oct 1, 2015

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IW-1701 Single Dose	Drug: IW-1701
Placebo Comparator: Matching Placebo for IW-1701 Single Dose	Drug: Matching Placebo

Arm

Intervention/Treatment

Experimental: IW-1701

Single Dose

Drug: IW-1701

Placebo Comparator: Matching Placebo for IW-1701

Single Dose

Drug: Matching Placebo

Outcome Measures

Primary Outcome Measures

Assessment of the safety and tolerability of IW-1701 in healthy subjects via adverse events [From baseline up to 8 days]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

Cyclerion Therapeutics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cyclerion Therapeutics

ClinicalTrials.gov Identifier:

NCT02572349

Other Study ID Numbers:

ICP-1701-101

First Posted:

Oct 8, 2015

Last Update Posted:

Apr 3, 2019

Last Verified:

Apr 1, 2019

Keywords provided by Cyclerion Therapeutics

Healthy Subjects

Study Results

No Results Posted as of Apr 3, 2019