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

NCT ID: NCT02092831

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Crossover sequence 1

Group Type EXPERIMENTAL

GDC-0941

Intervention Type DRUG

Single dose market image tablet of hardness 1

GDC-0941

Intervention Type DRUG

Single dose market image tablet of hardness 2

GDC-0941

Intervention Type DRUG

Single dose market image tablet of hardness 3

GDC-0941

Intervention Type DRUG

Single dose Phase 2 tablet formulation

Crossover sequence 2

Group Type EXPERIMENTAL

GDC-0941

Intervention Type DRUG

Single dose market image tablet of hardness 1

GDC-0941

Intervention Type DRUG

Single dose market image tablet of hardness 2

GDC-0941

Intervention Type DRUG

Single dose market image tablet of hardness 3

GDC-0941

Intervention Type DRUG

Single dose Phase 2 tablet formulation

Crossover sequence 3

Group Type EXPERIMENTAL

GDC-0941

Intervention Type DRUG

Single dose market image tablet of hardness 1

GDC-0941

Intervention Type DRUG

Single dose market image tablet of hardness 2

GDC-0941

Intervention Type DRUG

Single dose market image tablet of hardness 3

GDC-0941

Intervention Type DRUG

Single dose Phase 2 tablet formulation

Crossover sequence 4

Group Type EXPERIMENTAL

GDC-0941

Intervention Type DRUG

Single dose market image tablet of hardness 1

GDC-0941

Intervention Type DRUG

Single dose market image tablet of hardness 2

GDC-0941

Intervention Type DRUG

Single dose market image tablet of hardness 3

GDC-0941

Intervention Type DRUG

Single dose Phase 2 tablet formulation

Interventions

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GDC-0941

Single dose market image tablet of hardness 1

Intervention Type DRUG

GDC-0941

Single dose market image tablet of hardness 2

Intervention Type DRUG

GDC-0941

Single dose market image tablet of hardness 3

Intervention Type DRUG

GDC-0941

Single dose Phase 2 tablet formulation

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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GP29284

Identifier Type: -

Identifier Source: org_study_id