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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

The objectives of this study are: Stage 1: To assess the safety, tolerability, pharmacokinetic (PK) profile and pharmacodynamic (PD) effects of a range of doses of IW-1701 tablets administered orally to healthy subjects over 7 days of repeated dosing Stage 2: To assess the safety, tolerability, PK profile and PD effects of IW-1701 tablets administered orally to healthy subjects, in fed and fasted states, in an open-label, single-dose, 2-period, 2-sequence crossover study.

Key facts

Study ID

NCT02792998

Run by

Cyclerion Therapeutics

People needed

67

Starts

2016-05-01

Expected to finish

2016-11-01

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 at the time of check-in and must agree to use double-barrier contraception throughout the duration of the study
• 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 conditions
• Other exclusion criteria per protocol

Where it is running

• ICON Early Phase Unit — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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