Status:
COMPLETED
A Study Testing the Effect and Safety of Casopitant (GW679769) While Taking Warfarin in Healthy Human Volunteers
Lead Sponsor:
GlaxoSmithKline
Conditions:
Nausea and Vomiting, Chemotherapy-Induced
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
GW679769 may affect liver enzymes that metabolize warfarin. This study is designed to test the extent of the GW679769 affect on Warfarin levels in humans.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Healthy subjects
- non-smoking
- Females cannot be able to have children
- Must be able to swallow and retain oral medication
- Understand and sign the written consent
- comply with the requirements and restrictions involved in an overnight 30 day confinement in a healthcare setting
- Exclusion criteria:
- cannot participate if subject has a clinically relevant abnormality, medical condition, or circumstance that makes them unsuitable for the study per the study doctor.
- blood donation in excess of 1 pint within 56 days before dosing of medication
- iron deficiency
- history of drug or alcohol abuse or dependency within the past 6 months
- subjects cannot use any nicotine-containing products within the last 6 months
- positive for HIV, Hepatitis B or C
- use of prescription or non-prescription drug(s), herbal or dietary supplements or vitamins with 14 days prior to first dose of study medication
- consumption of any food or drink containing grapefruit, Seville oranges, kumquats, pomelos (or their juices) within 7 days of the first dose of study medication
- history of bleeding disorders or excessive bleeding
- female who has a positive pregnancy test
- female who is lactating
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2007
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT00404274
Start Date
November 1 2006
End Date
March 18 2007
Last Update
August 9 2017
Active Locations (2)
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1
GSK Investigational Site
Gainesville, Florida, United States, 32605
2
GSK Investigational Site
Buffalo, New York, United States, 14202