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

• Status: Completed
• Trial end date: 2007-03-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Casopitant; Warfarin

Criteria

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