A Study to Determine the Bioavailability of Various Formulations of GDC-0134 in Healthy Female Participants of Non-Childbearing Potential

NCT ID: NCT03807739

Last Updated: 2020-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2019-05-30

Brief Summary

This is a two-part study to determine the relative bioavailability of two different prototype capsules of GDC-0134 to that of an existing reference capsule of GDC-0134 under both fed and fasted conditions. The study is open to healthy female participants of non-childbearing potential.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part I: GDC-0134 F16 vs F09 Capsule Formulation

In Part 1 participants will receive single doses of either GDC-0134 F16 capsules (prototype) or GDC-0134 F09 capsules (reference) after having consumed a standard meal.

Group Type: EXPERIMENTAL

GDC-0134 F09 Formulation

Intervention Type: DRUG

Participants will receive a single oral dose of GDC-0134 reference capsule F09.

GDC-0134 F16 Formulation

Intervention Type: DRUG

Participants will receive a single oral dose of GDC-0134 prototype capsule F16.

Part II: GDC-0134 F15 vs F09 Capsule Formulation

In Part 2, participants will receive a single dose of either GDC-0134 F15 capsules (prototype) or GDC-0134 F09 capsules (reference) after an overnight fast.

Group Type: EXPERIMENTAL

GDC-0134 F09 Formulation

Intervention Type: DRUG

Participants will receive a single oral dose of GDC-0134 reference capsule F09.

GDC-0134 F15 Formulation

Intervention Type: DRUG

Participants will receive a single oral dose of GDC-0134 prototype capsule F15.

Interventions

GDC-0134 F09 Formulation

Participants will receive a single oral dose of GDC-0134 reference capsule F09.

Intervention Type: DRUG

GDC-0134 F15 Formulation

Participants will receive a single oral dose of GDC-0134 prototype capsule F15.

Intervention Type: DRUG

GDC-0134 F16 Formulation

Participants will receive a single oral dose of GDC-0134 prototype capsule F16.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Body mass index (BMI) range 18.5 to 35 kilograms per square meter (kg/m2)
• In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, and vital signs;
• Clinical laboratory evaluations within the reference range for the test laboratory, unless deemed not clinically significant by the principal investigators (PIs)
• Females of non-childbearing potential only

Exclusion Criteria

• History or clinical manifestation of any significant medical condition as determined by the PI (or designee)
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the PI (or designee)
• History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
• Use of any prescription medications/products within 14 days prior to Check-in (Day -1) for their first treatment period and during the entire study duration, unless deemed acceptable by the PI
• Use of oral antibiotics within 4 weeks or intravenous antibiotics within 8 weeks prior to the Screening evaluation and during the entire study duration
• Use of any over-the-counter, non-prescription preparations within 14 days prior to Check-in (Day -1) for their first treatment period and during the entire study duration, unless deemed acceptable by the PI
• Use of acid reducing medications (proton pump inhibitors [PPIs], histamine H2-receptor antagonists [H2RAs]) within 14 days prior to Check-in (Day -1) for their first treatment period and during the entire study duration. As an alternative, antacids may be allowed at least 4 hours before or after dose
• Use of any vaccines (including seasonal flu and H1N1 vaccines) within 14 days prior to Check-in (Day -1) for their first treatment period
• Use of tobacco- or nicotine-containing products within 6 months prior to Check-in (Day -1) for their first treatment period and during the entire study
• Any acute or chronic condition or any other reason that, in the opinion of the PI, would limit the subject's ability to complete and/or participate in this clinical study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Covance Research Unit - Daytona

Daytona Beach, Florida, United States

Covance Research Unit - Dallas

Dallas, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

GP40957

Identifier Type: -

Identifier Source: org_study_id