A 3-Part Study to Determine the Relative Bioavailability of Capsule and Tablet Formulations of GDC-0980, the Effect of Food, and the Effect of Rabeprazole on the Pharmacokinetics of the Tablet

Study Overview
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Brief Summary
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This will be a single-center, open-label, 3 part study. The study is designed to determine the relative bioavailability of GDC-0980 capsule and tablet formulations under fasting conditions, the effects of a high-fat (fed) meal on the pharmacokinetics of the GDC-0980 tablet, and the effects of rabeprazole on the pharmacokinetics of the GDC-0980 tablet in the presence or absence of a high-fat meal.

Official Title
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An Open-Label, 3-Part Study to Determine the Relative Bioavailability of Capsule and Tablet Formulations of GDC-0980, the Effect of Food, and the Effect of Rabeprazole on the Pharmacokinetics of the Tablet

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: GDC-0980
* Drug: GDC-0980
* Drug: GDC-0980
* Drug: GDC-0980
* Drug: GDC-0980
* Drug: GDC-0980
* Drug: rabeprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Nonsmoking with a body mass index of 18 to 32 kg/m2 Medically healthy as determined by the absence of clinically significant findings in the physical examination, medical history, vital sign measurements, clinical laboratory tests, or 12-lead electrocardiograms (ECGs) Nonchildbearing potential, defined as either postmenopausal and without recent history of menorrhea or surgically sterile Exclusion Criteria History or clinical manifestations of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, endocrine, gastrointestinal, urological, neurological, or psychiatric disorders, or cancer History of inflammatory arthritis History of symptomatic hypotension History of severe physical injury, direct impact trauma, or neurological trauma within 6 months prior to study start History of seizure disorders History of bipolar or major depressive disorder History of stomach or intestinal surgery or resection that could potentially alter absorption and/or excretion of orally administered drugs with the exception of appendectomy, hernia repair, and cholecystectomy, which are allowed History or presence of an abnormal ECG History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias Abnormality on the chest x-ray at Screening History of alcoholism, drug abuse, or drug addiction Used any nicotine-containing or nicotine-replacement products within 6 months prior to study start Participated in any other investigational drug study in which receipt of an investigational study drug occurred within 1 month or 5 half-lives prior to study start Used any prescription medications/products including monoamine oxidase inhibitors, thioridazine, pimozide, or antidepressants within 1 month (2 weeks for antibiotics) prior to study start, with the exception of hormone-replacement therapy or 2 weeks' use of narcotics for pain Received any vaccination or immunization within 1 month prior to study start Used PPIs or histamine H2-receptor antagonists within 1 month prior to study start Hypersensitivity to rabeprazole, or any of its components, or to derived products of benzimidazoles (for Part 3 only) Poor peripheral venous access Received blood products within 2 months prior to study start Positive urine drug or alcohol screen Positive screen for hepatitis B surface antigen, hepatitis C virus, or human immunodeficiency virus types 1 and 2 Unable to consume a high-fat meal (for Parts 2 and 3 only) Acute or chronic condition that would limit the subject's ability to complete 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1<br> | Drug: GDC-0980<br>* Oral tablet dose<br>Drug: GDC-0980<br>* Oral capsule dose<br>|
| Experimental: Part 2<br> | Drug: GDC-0980<br>* Oral tablet dose in fed state<br>Drug: GDC-0980<br>* Oral tablet in a fasting state<br>|
| Experimental: Part 3: Group A<br> | Drug: GDC-0980<br>* Oral repeating dose in fasting state<br>Drug: rabeprazole<br>* Oral repeating dose<br>|
| Experimental: Part 3: Group B<br> | Drug: GDC-0980<br>* Oral repeating dose in fed state<br>Drug: rabeprazole<br>* Oral repeating dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration |  | Up to day 10 | 
| Time to maximum observed plasma concentration |  | Up to day 10 | 
| Plasma half-life |  | Up to day 10 | 
| Oral clearance |  | Up to day 10 | 
| Volume of distribution |  | Up to day 10 | 
| Minimum plasma concentration |  | Up to day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | Up to day 68 | 
| Nature of adverse events |  | Up to day 68 | 
| Severity of adverse events |  | Up to day 68 |