A Study to Assess the Safety and Interaction Between Casopitant and Ketoconazole When Taken By Healthy Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00460707
First received: April 12, 2007
Last updated: May 31, 2012
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Healthy Subjects
Nausea and Vomiting, Chemotherapy-Induced
Drug: Casopitant
Drug: Ketoconazole
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Plasma levels of casopitant and ketoconazole will be checked on Day 4 to 9 in Cohort 1. [ Time Frame: Day 4 to 9 in Cohort 1. ]
  • Plasma levels of casopitant will be checked on Day 2 to 4 of Period 1 and [ Time Frame: Day 2 to 4 of Period 1 ]
  • casopitant and ketoconazole will be checked on Day 4 to 9 of Period 2. [ Time Frame: Day 4 to 9 of Period 2 ]

Secondary Outcome Measures:
  • Safety is evaluated in Cohort 1 by: - Clinical Lab Tests & Physical Exam at Screen, Day -1 & Followup (FU) [ Time Frame: at Screen, Day -1 & Followup (FU) ]
  • - Vitals Signs monitored at Screen, Day -1, 4-7 and FU [ Time Frame: at Screen, Day -1, 4-7 and FU ]
  • - 12 lead ECGs at Screen & FU [ Time Frame: at Screen & FU ]
  • - Adverse Events Monitoring starting at Day 1 [ Time Frame: Day 1 ]

Enrollment: 72
Study Start Date: April 2007
Intervention Details:
    Drug: Casopitant Drug: Ketoconazole
    Other Names:
    • Casopitant
    • Ketoconazole
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  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: NCT00460707

Locations
United States, Kansas
GSK Investigational Site
Overland Park, Kansas, United States, 66211
United States, New York
GSK Investigational Site
Buffalo, New York, United States, 14202
United States, Ohio
GSK Investigational Site
Columbus, Ohio, United States, 43212
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00460707     History of Changes
Other Study ID Numbers: NKV109990
Study First Received: April 12, 2007
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
GW679769
healthy adult subjects
casopitant
ketoconazole

Additional relevant MeSH terms:
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
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 July 22, 2014