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
This study has been completed.
Sponsor:
Genentech
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01287091
First received: January 7, 2011
Last updated: August 19, 2011
Last verified: August 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Volunteer |
Drug: GDC-0980 Drug: rabeprazole |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Genentech:
Primary Outcome Measures:
- Maximum plasma concentration [ Time Frame: Up to day 10 ] [ Designated as safety issue: No ]
- Time to maximum observed plasma concentration [ Time Frame: Up to day 10 ] [ Designated as safety issue: No ]
- Plasma half-life [ Time Frame: Up to day 10 ] [ Designated as safety issue: No ]
- Oral clearance [ Time Frame: Up to day 10 ] [ Designated as safety issue: No ]
- Volume of distribution [ Time Frame: Up to day 10 ] [ Designated as safety issue: No ]
- Minimum plasma concentration [ Time Frame: Up to day 10 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Incidence of adverse events [ Time Frame: Up to day 68 ] [ Designated as safety issue: No ]
- Nature of adverse events [ Time Frame: Up to day 68 ] [ Designated as safety issue: No ]
- Severity of adverse events [ Time Frame: Up to day 68 ] [ Designated as safety issue: No ]
| Enrollment: | 46 |
| Study Start Date: | October 2010 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Part 1 |
Drug: GDC-0980
Oral tablet dose
Drug: GDC-0980
Oral capsule dose
|
| Experimental: Part 2 |
Drug: GDC-0980
Oral tablet dose in fed state
Drug: GDC-0980
Oral tablet in a fasting state
|
| Experimental: Part 3: Group A |
Drug: GDC-0980
Oral repeating dose in fasting state
Drug: rabeprazole
Oral repeating dose
|
| Experimental: Part 3: Group B |
Drug: GDC-0980
Oral repeating dose in fed state
Drug: rabeprazole
Oral repeating dose
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Genentech |
| ClinicalTrials.gov Identifier: | NCT01287091 History of Changes |
| Other Study ID Numbers: | PIM4930g |
| Study First Received: | January 7, 2011 |
| Last Updated: | August 19, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Rabeprazole Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013