A Study Testing the Effect and Safety of Casopitant (GW679769) While Taking Warfarin in Healthy Human Volunteers

Completed · Phase 1

Conditions studied: Nausea and Vomiting, Chemotherapy-Induced

In brief

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.

Key facts

Study ID

NCT00404274

Run by

GlaxoSmithKline

People needed

97

Starts

2006-11-01

Expected to finish

2007-03-18

Last updated by the study team

2017-08-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Gainesville, Florida, United States
• GSK Investigational Site — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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