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

NCT01473316 | Completed Phase 1

• 1 other identifier: GP27913
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics: maximum observed plasma concentration

  Up to approximately 10 days

• Pharmacokinetics: time to reach maximum observed plasma concentration

  Up to approximately 10 days

Secondary Outcomes (3)

• Adverse events

  Up to approximately 40 days

• Clinical laboratory test results (hematology and serum chemistry)

  Up to approximately 10 days

• Vital sign measurements (sitting systolic and diastolic blood pressure, heart rate, respiratory rate, and temperature)

  Up to approximately 8 days

Study Arms (1)

A

EXPERIMENTAL

Drug: GDC-0980; Drug: Ketoconazole

Interventions

GDC-0980 DRUG

Single oral dose

A

Ketoconazole DRUG

Repeating Oral Dose

A

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (1)

Unknown Facility

Austin, Texas, 78744, United States

Location

MeSH Terms

Interventions

1-(4-((2-(2-aminopyrimidin-5-yl)-7-methyl-4-morpholinothieno(3,2-d)pyrimidin-6-yl)methyl)piperazin-1-yl)-2-hydroxypropan-1-one; Ketoconazole

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2011
• First Posted: November 17, 2011
• Study Start: November 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

US (1)