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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: ipatasertib (Capsule); Drug: ipatasertib (Tablet)

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Clinically significant findings from medical history or screening evaluations

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1: Tablet followed by Capsule	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.
Experimental: Sequence 2: Capsule followed by Tablet	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the concentration time curve (AUC) of ipatasertib	Days 1-13
Maximum concentration (Cmax) reached of ipatasertib	Days 1-13
Time to maximum concentration (Tmax) of ipatasertib	Days 1-13

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events	From check-in (Day -1) to Day 13

Collaborators and Investigators

• Sponsor: Genentech, Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: February 12, 2014
• First Submitted That Met QC Criteria: February 12, 2014
• First Posted (Estimate): February 14, 2014

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: GP29066