A Phase 1 interventional study of ipatasertib (Capsule) and ipatasertib (Tablet) in Healthy Volunteer, sponsored by Genentech, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-02.
Sponsored by Genentech, Inc. · Phase 1, Interventional, and Treatment
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.
Genentech, Inc. is the lead sponsor of 507 studies on the registry; 23 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 50 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: ipatasertib (Capsule) · Drug: ipatasertib (Tablet)
Drug: ipatasertib (Capsule) · Drug: ipatasertib (Tablet)
Orally administered single dose of Ipatasertib formulated as a capsule.
Orally administered single dose of Ipatasertib formulated as a tablet.
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 study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Genentech, Inc.