drugset / Trial / NCT02063581

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

NCT02063581

Phase 1 Completed 16 enrolled Genentech, Inc.
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2014-02
Primary completion
2014-03
Completion
2014-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Ipatasertib Small molecule Oral

Indications

No indication recorded.