Clinical trial
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
Name
PIM4930g
Description
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.
Trial arms
Trial start
2010-10-14
Estimated PCD
2011-02-03
Trial end
2011-02-03
Status
Completed
Phase
Early phase I
Treatment
GDC-0980
Oral tablet dose
Arms:
Part 1
GDC-0980
Oral capsule dose
Arms:
Part 1
GDC-0980
Oral tablet dose in fed state
Arms:
Part 2
GDC-0980
Oral repeating dose in fasting state
Arms:
Part 3: Group A
GDC-0980
Oral repeating dose in fed state
Arms:
Part 3: Group B
GDC-0980
Oral tablet in a fasting state
Arms:
Part 2
rabeprazole
Oral repeating dose
Arms:
Part 3: Group A, Part 3: Group B
Size
46
Primary endpoint
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
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 46, 'type': 'ACTUAL'}}
Updated at
2022-12-13
1 organization
2 products
1 indication
Product
GDC-0980Indication
Healthy VolunteerOrganization
GenentechProduct
rabeprazole