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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 1

Conditions

Nausea and Vomiting, Chemotherapy-Induced

Treatments

Drug: Warfarin oral tablets

Drug: Casopitant (GW679769) oral tablets

Study type

Interventional

Funder types

Industry

Identifiers

NCT00404274

NKV105097

Details and patient eligibility

About

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.

Enrollment

97 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

97 participants in 3 patient groups

Treatment regimen A

Experimental group

Description:

In treatment regimen A subject will co-administer casopitant and warfarin over three-day period (Day 1 150 milligram per day \[mg/day\], Day 2 50 mg/day, Day 3 50 mg/day) and from Days 4 to 10 subject will administer only warfarin.

Treatment:

Drug: Warfarin oral tablets

Drug: Casopitant (GW679769) oral tablets

Treatment regimen B

Experimental group

Description:

In treatment regimen B subject will co-administer casopitant 60 mg/day and warfarin for 14 days.

Treatment:

Drug: Warfarin oral tablets

Drug: Casopitant (GW679769) oral tablets

Treatment regimen C

Experimental group