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

Cyclerion Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Matching Placebo; Drug: IW-1701

Study type: Interventional

Funder types: Industry

Identifiers

NCT02572349

ICP-1701-101

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups, including a placebo group

IW-1701

Experimental group

Description:

Single Dose

Treatment:

Drug: IW-1701

Matching Placebo for IW-1701

Placebo Comparator group

Description:

Single Dose

Treatment:

Drug: Matching Placebo