Healthy
Conditions
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.
Interventions
DRUGIW-1973
IW-1973 Tablet
Matching placebo tablet
Sponsors
Cyclerion Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| Serum cGMP | 42 Days |
Countries
United States
Outcome results
None listed