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

NCT03807739 | Completed Phase 1 Results FDA Drug

• 1 other identifier: GP40957
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• Maximum Observed Concentration (Cmax) of GDC-0134.

  The time points at which the outcome measure was assessed were 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 336, 504 hours post-dose.

• Area Under the Curve Extrapolated to Infinity (AUCinf) of GDC-0134

  The time points at which the outcome measure was assessed were 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 336, 504 hours post-dose.

Secondary Outcomes (1)

• Percentage of Participants With Adverse Events (AEs)

  From baseline through the end of study (approximately 11 weeks)

Study Arms (2)

Part I: GDC-0134 F16 vs F09 Capsule Formulation

EXPERIMENTAL

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.

Drug: GDC-0134 F09 Formulation; Drug: GDC-0134 F16 Formulation

Part II: GDC-0134 F15 vs F09 Capsule Formulation

EXPERIMENTAL

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.

Drug: GDC-0134 F09 Formulation; Drug: GDC-0134 F15 Formulation

Interventions

GDC-0134 F09 Formulation DRUG

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

Part I: GDC-0134 F16 vs F09 Capsule Formulation; Part II: GDC-0134 F15 vs F09 Capsule Formulation

GDC-0134 F15 Formulation DRUG

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

Part II: GDC-0134 F15 vs F09 Capsule Formulation

GDC-0134 F16 Formulation DRUG

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

Part I: GDC-0134 F16 vs F09 Capsule Formulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Healthy female participants of non-childbearing potential
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (2)

Covance Research Unit - Daytona

Daytona Beach, Florida, 32117, United States

Location

Covance Research Unit - Dallas

Dallas, Texas, 75247, United States

Location

Results Point of Contact

• Title: Medical Communications
• Organization: Genentech, Inc

genentech@druginfo.com

1-800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 17, 2019
• Study Start: February 1, 2019
• Primary Completion: May 30, 2019
• Study Completion: May 30, 2019
• Last Updated: August 31, 2020
• Results First Posted: August 31, 2020

Record last verified: 2020-08

Locations

US (2)