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

Cyclerion Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Matching Placebo Tablet; Drug: IW-1973

Study type: Interventional

Funder types: Industry

Identifiers

NCT02616861

ICP-1973-102

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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54 participants in 2 patient groups, including a placebo group

IW-1973

Experimental group

Description:

1973 Escalating Doses

Treatment:

Drug: IW-1973

Placebo

Placebo Comparator group

Description:

Matching Placebo

Treatment:

Drug: Matching Placebo Tablet