Status:
COMPLETED
A Study to Assess the Safety and Interaction Between Casopitant and Ketoconazole When Taken By Healthy Adults
Lead Sponsor:
GlaxoSmithKline
Conditions:
Nausea and Vomiting, Chemotherapy-Induced
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 16 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 27 2007
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT00460707
Start Date
April 16 2007
End Date
August 27 2007
Last Update
August 3 2017
Active Locations (3)
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1
GSK Investigational Site
Overland Park, Kansas, United States, 66211
2
GSK Investigational Site
Buffalo, New York, United States, 14202
3
GSK Investigational Site
Columbus, Ohio, United States, 43212