A Study of the Effect of Formulation and Tablet Hardness on the Bioavailability of Pictilisib in Healthy Volunteers

November 1, 2016 updated by: Genentech, Inc.

A PHASE 1, OPEN-LABEL STUDY TO EVALUATE THE EFFECT OF FORMULATION AND TABLET HARDNESS ON THE RELATIVE BIOAVAILABILITY OF PICTILISIB (GDC-0941) IN HEALTHY SUBJECTS

This Phase 1, open-label, randomized, 4-period crossover study is designed to determine the relative bioavailability of GDC-0941 administered as a single dose of the market image formulation at 3 different hardnesses (hardness 1, 2, and 3) and as a single dose of the Phase 2 formulation to healthy male and female volunteers. Participants will be randomly assigned to 4 possible treatment sequences, each comprising 4 periods (1 per formulation), and GDC-0941 will be administered based on the assigned sequence. The study is expected to last 8 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female participants between 18 and 55 years of age, inclusive,
  • Body mass index (BMI) between 18.5 to 32 kg/m2, inclusive,
  • Healthy, as determined by no clinically significant findings from medical history, ECG, and vital signs, and who are able to swallow and tolerate a tethered Heidelberg pH Capsule and have gastric pH measurements taken

Exclusion Criteria:

  • Any medical condition or history of such condition that may, in the opinion of the investigator, contraindicate participation in this study

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Crossover sequence 1
Drug: GDC-0941
Single dose market image tablet of hardness 1
Drug: GDC-0941
Single dose market image tablet of hardness 2
Drug: GDC-0941
Single dose market image tablet of hardness 3
Drug: GDC-0941
Single dose Phase 2 tablet formulation
EXPERIMENTAL: Crossover sequence 2
Drug: GDC-0941
Single dose market image tablet of hardness 1
Drug: GDC-0941
Single dose market image tablet of hardness 2
Drug: GDC-0941
Single dose market image tablet of hardness 3
Drug: GDC-0941
Single dose Phase 2 tablet formulation
EXPERIMENTAL: Crossover sequence 3
Drug: GDC-0941
Single dose market image tablet of hardness 1
Drug: GDC-0941
Single dose market image tablet of hardness 2
Drug: GDC-0941
Single dose market image tablet of hardness 3
Drug: GDC-0941
Single dose Phase 2 tablet formulation
EXPERIMENTAL: Crossover sequence 4
Drug: GDC-0941
Single dose market image tablet of hardness 1
Drug: GDC-0941
Single dose market image tablet of hardness 2
Drug: GDC-0941
Single dose market image tablet of hardness 3
Drug: GDC-0941
Single dose Phase 2 tablet formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the concentration-time curve (AUC) of plasma GDC-0941
Time Frame: 25 Days
25 Days
Maximum plasma concentration (Cmax) of GDC-0941
Time Frame: 25 Days
25 Days
Relative bioavailability (Frel) according to the model independent approach
Time Frame: 25 days
25 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events
Time Frame: 25 days
25 days
Electrocardiogram (ECG)
Time Frame: 25 days
25 days

Collaborators and Investigators

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

Sponsor

Genentech, Inc.

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

April 1, 2014

Primary Completion (ACTUAL)

May 1, 2014

Study Completion (ACTUAL)

May 1, 2014

Study Registration Dates

First Submitted

March 18, 2014

First Submitted That Met QC Criteria

March 18, 2014

First Posted (ESTIMATE)

March 20, 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

  • GP29284

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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