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

Genentech

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: rabeprazole; Drug: GDC-0980

Study type: Interventional

Funder types: Industry

Identifiers

NCT01287091

PIM4930g

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 4 patient groups

Part 1

Experimental group

Treatment:

Drug: GDC-0980

Drug: GDC-0980

Drug: GDC-0980

Drug: GDC-0980

Drug: GDC-0980

Drug: GDC-0980

Part 2

Experimental group

Treatment:

Drug: GDC-0980

Drug: GDC-0980

Drug: GDC-0980

Drug: GDC-0980

Drug: GDC-0980

Drug: GDC-0980

Part 3: Group A

Experimental group

Treatment:

Drug: GDC-0980

Drug: GDC-0980

Drug: GDC-0980

Drug: GDC-0980

Drug: rabeprazole

Drug: GDC-0980

Drug: GDC-0980

Part 3: Group B

Experimental group

Treatment:

Drug: GDC-0980

Drug: GDC-0980

Drug: GDC-0980

Drug: GDC-0980

Drug: rabeprazole

Drug: GDC-0980

Drug: GDC-0980