Study to Determine the Effect of Ketoconazole on the Pharmacokinetics of GDC-0980
This study has been completed.
Sponsor:
Genentech
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01473316
First received: November 10, 2011
Last updated: July 18, 2012
Last verified: July 2012
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Purpose
This will be an open-label, fixed-sequence, single-center, 2 period study. The study is designed to determine the effect of ketoconazole on the pharmacokinetics of GDC-0980.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Volunteer |
Drug: GDC-0980 Drug: Ketoconazole |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label, Fixed-Sequence, 2-Period Study to Determine the Effect of Ketoconazole on the Pharmacokinetics of GDC-0980 |
Resource links provided by NLM:
Further study details as provided by Genentech:
Primary Outcome Measures:
- Pharmacokinetics: maximum observed plasma concentration [ Time Frame: Up to approximately 10 days ] [ Designated as safety issue: No ]
- Pharmacokinetics: time to reach maximum observed plasma concentration [ Time Frame: Up to approximately 10 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Adverse events [ Time Frame: Up to approximately 40 days ] [ Designated as safety issue: No ]
- Clinical laboratory test results (hematology and serum chemistry) [ Time Frame: Up to approximately 10 days ] [ Designated as safety issue: No ]
- Vital sign measurements (sitting systolic and diastolic blood pressure, heart rate, respiratory rate, and temperature) [ Time Frame: Up to approximately 8 days ] [ Designated as safety issue: No ]
| Enrollment: | 22 |
| Study Start Date: | November 2011 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: GDC-0980
Single oral dose
Drug: Ketoconazole
Repeating Oral Dose
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy postmenopausal and/or surgically sterile adult nonsmoking female subject between 18 and 65 years of age, inclusive, with a body mass index of 18 to 32 kg/m2, inclusive
- 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) as determined by the investigator
- Female subject of nonchildbearing potential
Exclusion Criteria:
- History or clinical manifestations of significant metabolic (including type 1 and 2 diabetes), hepatic, renal, hematological (including hypercholesterolemia and triglyceridemia), pulmonary, cardiovascular, endocrine, gastrointestinal (including gastric or duodenal ulcers), 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 before Day 1 of Period 1
- 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 of active liver disease, including hepatitis or cirrhosis
- 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 determined to be clinically significant by the investigator and medical monitor
- History of alcoholism, drug abuse, or drug addiction
- Used any nicotine-containing or nicotine-replacement products within 6 months before Day 1 of Period 1
- Participated in any other investigational drug study in which receipt of an investigational study drug occurred within 1 month or 5 half-lives before Day 1 of Period 1
- Used any prescription medications/products including monoamine oxidase inhibitors, thioridazine, pimozide, or antidepressants within 1 month (2 weeks for antibiotics) before Day 1 of Period 1, with the exception of hormone replacement therapy or 2 weeks' use of narcotics for pain, unless deemed acceptable by the investigator
- Used medications capable of inhibiting hepatic enzymes within 1 month or 5 half-lives before Day 1 of Period 1
- Received any vaccination or immunization within 1 month before Day 1 of Period 1
- Used proton pump inhibitors or histamine H2 receptor antagonists within 1 month before Day 1 of Period 1
- Known hypersensitivity to ketoconazole, or other azole antifungals
- Used any over-the-counter, nonprescription preparations within 7 days before Day 1 of Period 1, unless deemed acceptable by the investigator
- Used alcohol-containing, grapefruit-containing, or caffeine containing foods or beverages within 72 hours before Day 1 of Period 1, unless deemed acceptable by the investigator
- Poor peripheral venous access
- Donated blood within 2 weeks or plasma within 1 week before Day 1 of Period 1
- Received blood products within 2 months before Day 1 of Period 1
- Positive urine drug or alcohol screen
- Positive screen for hepatitis B surface antigen, hepatitis C virus, or human immunodeficiency virus types 1 and 2
- Diagnosed with a vitamin B12 deficiency
- Any acute or chronic condition that, in the opinion of the investigator, 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: | NCT01473316 History of Changes |
| Other Study ID Numbers: | GP27913 |
| Study First Received: | November 10, 2011 |
| Last Updated: | July 18, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Ketoconazole 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antifungal Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013