Ipatasertib (GDC-0068) Study to Evaluate Formulation Change and Food Effect on Bioavailability in Healthy Subjects

Completed · Phase 1

Conditions studied: Cancer

In brief

This Phase I, open-label, randomized, 3-period crossover study was designed to determine the relative bioavailability of ipatasertib administered as capsule and tablet formulations to healthy volunteers. In addition, the influence of food on ipatasertib exposure will also be determined. Participants will be randomized to one of six treatment sequences to receive three treatments of a single oral administration of ipatasertib in, 1) tablet formulation in the fasted state, 2) capsule formulation in the fasted state or 3) tablet formulation in the fed state. Pharmacokinetics will be assessed, and standard physical and clinical evaluations will be performed throughout the study. Time on study is expected to be 3 weeks.

Key facts

Study ID

NCT02536391

Run by

Genentech, Inc.

People needed

18

Starts

2015-10-01

Expected to finish

2015-11-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy males or females, between 18 and 55 years of age, inclusive
• Body mass index between 18.5 and 29.9 kg/m\^2, inclusive

You may not qualify if…

• Clinically significant findings from medical history or screening evaluations.

Where it is running

• Study site — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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