A Study Evaluating the Effect of Formulation on the Bioavailability of Ipatasertib in Healthy Volunteers

Completed · Phase 1

Conditions studied: Healthy Volunteer

In brief

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.

Key facts

Study ID

NCT02063581

Run by

Genentech, Inc.

People needed

16

Starts

2014-02-01

Expected to finish

2014-03-01

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 male and female volunteers aged 18 to 55 years, inclusive
• Body mass index (BMI) from 18.5-29.9 kg/m2, 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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