NCT02536391

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

A Phase 1, Single-Dose, Randomized, Cross-Over, Relative Bioavailability, and Food Effect Study of Ipatasertib (GDC-0068) in Healthy Subjects

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

Summary

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.

Conditions

• Cancer

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: 2015-10-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2015-08-31
• Last updated: 2016-11-02

Locations

1 site across 1 country: United States