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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
54
IW-1973 Tablet
Matching placebo tablet
Ironwood Investigator
San Antonio, Texas, United States
Treatment Emergent Adverse Events
Time frame: 42 Days
Maximum observed plasma concentration (Cmax)
Time frame: 42 Days
Blood Pressure
Time frame: 42 days
Area under the plasma concentration time curve during a dosing interval (AUC)
Time frame: 42 Days
Time of maximum observed plasma concentration (Tmax)
Time frame: 42 Days
Heart rate
Time frame: 42 Days
Serum cGMP
Time frame: 42 Days
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