Study to Determine the Effect of Ketoconazole on the Pharmacokinetics of GDC-0980

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01473316
First received: November 10, 2011
Last updated: September 2, 2014
Last verified: September 2014
  Purpose

This will be an open-label, fixed-sequence, single-center, 2 period study. The s tudy 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: December 2011
Primary Completion Date: December 2011 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01473316

Locations
United States, Texas
Austin, Texas, United States, 78744
Sponsors and Collaborators
Genentech
Investigators
Study Director: Clinical Trials Genentech
  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: September 2, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ketoconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014