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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT02616861

Run by

Cyclerion Therapeutics

People needed

54

Starts

2015-11-01

Expected to finish

2016-06-01

Last updated by the study team

2019-04-03

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• History of any clinically significant medical condition
• Other exclusion criteria per protocol

Where it is running

• Ironwood Investigator — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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