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

November 1, 2016 updated by: Genentech, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 males or females, between 18 and 55 years of age, inclusive
  • Body mass index between 18.5 and 29.9 kg/m^2, inclusive

Exclusion Criteria:

- Clinically significant findings from medical history or screening evaluations.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence 1: Tablet/Capsule/Tablet with food
Day 1: ipatasertib tablet administered after fast, Day 8: ipatasertib capsule administered after fast, Day 15: ipatasertib tablet administered after high-fat meal.
Drug: Ipatasertib (capsule)
Orally administered single dose of Ipatasertib formulated as a capsule.
Other Names:
  • GDC-0068 (capsule)
Drug: Ipatasertib (tablet)
Orally administered single dose of Ipatasertib formulated as a tablet.
Other Names:
  • GDC-0068 (tablet)
Experimental: Sequence 2: Tablet/Tablet with food/Capsule
Day 1: ipatasertib tablet administered after fast, Day 8: ipatasertib tablet administered after high-fat meal, Day 15: ipatasertib capsule administered after fast.
Drug: Ipatasertib (capsule)
Orally administered single dose of Ipatasertib formulated as a capsule.
Other Names:
  • GDC-0068 (capsule)
Drug: Ipatasertib (tablet)
Orally administered single dose of Ipatasertib formulated as a tablet.
Other Names:
  • GDC-0068 (tablet)
Experimental: Sequence 3: Capsule/Tablet/Tablet with food
Day 1: ipatasertib capsule administered after fast, Day 8: ipatasertib tablet administered after fast, Day 15: ipatasertib tablet administered after high-fat meal.
Drug: Ipatasertib (capsule)
Orally administered single dose of Ipatasertib formulated as a capsule.
Other Names:
  • GDC-0068 (capsule)
Drug: Ipatasertib (tablet)
Orally administered single dose of Ipatasertib formulated as a tablet.
Other Names:
  • GDC-0068 (tablet)
Experimental: Sequence 4: Capsule/Tablet with food/Tablet
Day 1: ipatasertib capsule administered after fast, Day 8: ipatasertib tablet administered after high-fat meal, Day 15: ipatasertib tablet administered after fast.
Drug: Ipatasertib (capsule)
Orally administered single dose of Ipatasertib formulated as a capsule.
Other Names:
  • GDC-0068 (capsule)
Drug: Ipatasertib (tablet)
Orally administered single dose of Ipatasertib formulated as a tablet.
Other Names:
  • GDC-0068 (tablet)
Experimental: Sequence 5: Tablet with food/Tablet/Capsule
Day 1: ipatasertib tablet administered after high-fat meal, Day 8: ipatasertib tablet administered after fast, Day 15: ipatasertib capsule administered after fast.
Drug: Ipatasertib (capsule)
Orally administered single dose of Ipatasertib formulated as a capsule.
Other Names:
  • GDC-0068 (capsule)
Drug: Ipatasertib (tablet)
Orally administered single dose of Ipatasertib formulated as a tablet.
Other Names:
  • GDC-0068 (tablet)
Experimental: Sequence 6: Tablet with food/Capsule/Tablet
Day 1: ipatasertib tablet administered after high-fat meal, Day 8: ipatasertib capsule administered after fast, Day 15: ipatasertib tablet administered after fast.
Drug: Ipatasertib (capsule)
Orally administered single dose of Ipatasertib formulated as a capsule.
Other Names:
  • GDC-0068 (capsule)
Drug: Ipatasertib (tablet)
Orally administered single dose of Ipatasertib formulated as a tablet.
Other Names:
  • GDC-0068 (tablet)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum Observed Concentration (Cmax) of Ipatasertib
Time Frame: Days 1, 8 and 15
Days 1, 8 and 15
Time to Maximum Concentration (tmax) of Ipatasertib
Time Frame: Days 1, 8 and 15
Days 1, 8 and 15
Area Under the Concentration-time Curve (AUC) from Hour 0 to the Last Quantifiable Concentration (AUC0-t) of Ipatasertib
Time Frame: Days 1, 8 and 15
Days 1, 8 and 15
Area Under the Concentration-time Curve (AUC) from Hour 0 Extrapolated to Infinity
Time Frame: Days 1, 8 and 15
Days 1, 8 and 15
Apparent Terminal Elimination Half-Life (t1/2) of Ipatasertib
Time Frame: Days 1, 8 and 15
Days 1, 8 and 15
Apparent Total Clearance (CL/F) of Ipatasertib
Time Frame: Days 1, 8 and 15
Days 1, 8 and 15
Apparent Volume of Distribution (Vz/F) of Ipatasertib
Time Frame: Days 1, 8 and 15
Days 1, 8 and 15

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with Adverse Events
Time Frame: From check in (Day -1) to 30 days after the last dose of study drug
From check in (Day -1) to 30 days after the last dose of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

August 27, 2015

First Submitted That Met QC Criteria

August 27, 2015

First Posted (Estimate)

August 31, 2015

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

  • GO29868

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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