Trial of IW-1973 (A Stimulator of Soluble Guanylate Cyclase (sGC)) in Healthy Volunteers
- Registration Number
- NCT02616861
- Lead Sponsor
- Cyclerion Therapeutics
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Matching Placebo Tablet Matching Placebo IW-1973 IW-1973 1973 Escalating Doses
- Primary Outcome Measures
Name Time Method Serum cGMP 42 Days Treatment Emergent Adverse Events 42 Days Maximum observed plasma concentration (Cmax) 42 Days Blood Pressure 42 days Area under the plasma concentration time curve during a dosing interval (AUC) 42 Days Time of maximum observed plasma concentration (Tmax) 42 Days Heart rate 42 Days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ironwood Investigator
🇺🇸San Antonio, Texas, United States