Clinical trial NCT01287091: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2011-02-01
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Maximum plasma concentration
timeFrame: Up to day 10
measure: Time to maximum observed plasma concentration
timeFrame: Up to day 10
measure: Plasma half-life
timeFrame: Up to day 10
measure: Oral clearance
timeFrame: Up to day 10
measure: Volume of distribution
timeFrame: Up to day 10
measure: Minimum plasma concentration
timeFrame: Up to day 10
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: Up to day 68
measure: Nature of adverse events
timeFrame: Up to day 68
measure: Severity of adverse events
timeFrame: Up to day 68
Other outcomes:
Locations:
city: Austin
country: United States
facility: Investigational Site
state: Texas
Study officials:
affiliation: Genentech, Inc.
name: Scott Holden, M.D.
role: STUDY_DIRECTOR
References: