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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
67
ICON Early Phase Unit
San Antonio, Texas, United States
Treatment Emergent Adverse Event
Time frame: 47 Days
Maximum observed plasma concentration [Cmax]
Maximum observed Plasma Concentration
Time frame: 47 Days
Area under the plasma concentration time curve during a dosing interval [AUC]
Area under the plasma concentration time curve during a dosing interval
Time frame: 47 Days
Time of maximum observed plasma concentration [Tmax]
Time of maximum observed plasma concentration
Time frame: 47 Days
Blood Pressure
Time frame: 47 Days
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