A Study to Assess the Safety and Interaction Between Casopitant and Ketoconazole When Taken By Healthy Adults
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Adult Volunteer
Intervention: Casopitant (Drug); Ketoconazole (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Chair, Affiliation: GlaxoSmithKline
Summary
Casopitant may affect liver enzymes that metabolize ketoconazole. This study is designed to
test the safety and the extent of the Casopitant affect on ketoconazole levels in healthy
human subjects.
Clinical Details
Official title: A Phase I, Randomized, Double-Blind Study to Assess the Effects of Repeat Oral Dosing of Ketoconazole on the Pharmacokinetics of Repeat Oral Dosing of Casopitant [GW679769] in Healthy Subjects
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacokinetics Study
Primary outcome: Plasma levels of casopitant and ketoconazole will be checked on Day 4 to 9 in Cohort 1.Plasma levels of casopitant will be checked on Day 2 to 4 of Period 1 and casopitant and ketoconazole will be checked on Day 4 to 9 of Period 2.
Secondary outcome: Safety is evaluated in Cohort 1 by:
- Clinical Lab Tests & Physical Exam at Screen, Day -1 & Followup (FU)- Vitals Signs monitored at Screen, Day -1, 4-7 and FU - 12 lead ECGs at Screen & FU - Adverse Events Monitoring starting at Day 1
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion criteria:
- A female subject who is non-childbearing potential or using acceptable contraceptive
methods.
- Adequate organ system functions.
- Able to swallow and retain oral medication.
- Subject is able to understand and comply with protocol requirements and instruction
and is likely to complete the study.
Exclusion Criteria:
- Current clinically relevant abnormality, medical condition, or circumstance that makes
the subject unsuitable for the study per the study doctor.
- History of drug or other allergy which, in the opinion of the study doctor,
contraindicates participation.
- Use of an investigational drug within 28 days or 5 half-lives.
- Use of prescription or non-prescription drugs, supplements or vitamins (excluding
multivitamins) within 14 days, or 5 half-lives prior to first dose of study
medication.
- Blood donation in excess of 500mL within 56 days prior to dosing or intends to donate
within 30 days of the post-treatment follow-up visit.
- Iron deficiency.
- Positive stool for occult blood.
- Female subject who is pregnant or lactating.
- Male subject who has a history of hypogonadism.
- Positive urine drug screen.
- Positive for HIV antibody, hepatitis C antibody or hepatitis B surface antigen.
- Use of tobacco-containing products within the past 12 months prior to screening.
- History of drug or alcohol abuse or dependence within 6 months of screening.
- History or presence of uncontrolled emesis.
- Presence of active infection.
- History of cholecystectomy or biliary tract disease.
- Active peptic ulcer disease (PUD) or a history of PUD of unknown etiology.
- Any degree of heart failure.
- Consumption of any food or drink containing grapefruit or grapefruit juice, apple
juice, Seville oranges, kumquats, pommelos or vegetables from the mustard green family
within 7 days prior to the first dose unless prior approval is received.
Locations and Contacts
GSK Clinical Trials Call Center, Lenexa, Kansas 66219, United States
GSK Clinical Trials Call Center, Buffalo, New York 14202, United States
GSK Clinical Trials Call Center, Columbus, Ohio 43212, United States
Additional Information
Starting date: April 2007
Last updated: September 18, 2007
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