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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I Study to Determine the Relative Bioavailability of Various Formulations of GDC-0134 in Healthy Female Subjects of Non-Childbearing Potential

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: GDC-0134 F09 Formulation
* Drug: GDC-0134 F15 Formulation
* Drug: GDC-0134 F16 Formulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part I: GDC-0134 F16 vs F09 Capsule Formulation<br>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<br>* Participants will receive a single oral dose of GDC-0134 reference capsule F09.<br>Drug: GDC-0134 F16 Formulation<br>* Participants will receive a single oral dose of GDC-0134 prototype capsule F16.<br>|
| Experimental: Part II: GDC-0134 F15 vs F09 Capsule Formulation<br>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<br>* Participants will receive a single oral dose of GDC-0134 reference capsule F09.<br>Drug: GDC-0134 F15 Formulation<br>* Participants will receive a single oral dose of GDC-0134 prototype capsule F15.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Adverse Events (AEs) |  | From baseline through the end of study (approximately 11 weeks) |