NCT02063581

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

A Phase 1, Open-Label Study to Evaluate the Effect of Formulation on the Bioavailability of Ipatasertib (GDC-0068) in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	ipatasertib (Capsule)	Orally administered single dose of Ipatasertib formulated as a capsule.
DRUG	ipatasertib (Tablet)	Orally administered single dose of Ipatasertib formulated as a tablet.

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2014-02-14
• Last updated: 2016-11-02

Locations

1 site across 1 country: United States