Study to Determine the Effect of Ketoconazole on the Pharmacokinetics of GDC-0980
An Open-Label, Fixed-Sequence, 2-Period Study to Determine the Effect of Ketoconazole on the Pharmacokinetics of GDC-0980
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78744
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
EXPERIMENTAL: A
|
Single oral dose
Repeating Oral Dose
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Pharmacokinetics: maximum observed plasma concentration
Time Frame: Up to approximately 10 days
|
Up to approximately 10 days
|
|
Pharmacokinetics: time to reach maximum observed plasma concentration
Time Frame: Up to approximately 10 days
|
Up to approximately 10 days
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Adverse events
Time Frame: Up to approximately 40 days
|
Up to approximately 40 days
|
|
Clinical laboratory test results (hematology and serum chemistry)
Time Frame: Up to approximately 10 days
|
Up to approximately 10 days
|
|
Vital sign measurements (sitting systolic and diastolic blood pressure, heart rate, respiratory rate, and temperature)
Time Frame: Up to approximately 8 days
|
Up to approximately 8 days
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (ACTUAL)
Primary Completion
Study Completion (ACTUAL)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
First Posted
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Antifungal Agents
- Steroid Synthesis Inhibitors
- 14-alpha Demethylase Inhibitors
- Ketoconazole
Other Study ID Numbers
Other Study ID Numbers
- GP27913
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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