This Phase I, open-label, randomized, 2-period crossover study was designed to determine the relative bioavailability of ipatasertib administered as capsule and tablet formulations to healthy adult volunteers. Participants will be randomized to one of two treatment sequences to receive a single oral administration of ipatasertib in tablet or capsule formulation followed, after a washout period, by a single oral administration of ipatasertib in the second formulation. Pharmacokinetics will be assessed, and standard physical and clinical evaluations will be performed throughout the study. Time on study is expected to be 2 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Orally administered single dose of Ipatasertib formulated as a capsule.
Orally administered single dose of Ipatasertib formulated as a tablet.
Unnamed facility
Madison, Wisconsin, United States
Area under the concentration time curve (AUC) of ipatasertib
Time frame: Days 1-13
Maximum concentration (Cmax) reached of ipatasertib
Time frame: Days 1-13
Time to maximum concentration (Tmax) of ipatasertib
Time frame: Days 1-13
Incidence of adverse events
Time frame: From check-in (Day -1) to Day 13
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.