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

Study Overview
=================
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.

Official Title
-----------------
An Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Steady-State Warfarin When Co-administered With Repeat Doses of Casopitant [GW679769] in Healthy Adult Subjects.

Conditions
-----------------
Nausea and Vomiting, Chemotherapy-Induced

Intervention / Treatment
-----------------
* Drug: Casopitant (GW679769) oral tablets
* Drug: Warfarin oral tablets


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment regimen A<br>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. | Drug: Casopitant (GW679769) oral tablets<br>* Casopitant will be available in the dose strength of 20,30 or 50 mg<br>Drug: Warfarin oral tablets<br>* Warfarin will be available in the dose strength of 5 mg<br>* Other names: Casopitant (GW679769) oral tablets;|
| Experimental: Treatment regimen B<br>In treatment regimen B subject will co-administer casopitant 60 mg/day and warfarin for 14 days. | Drug: Casopitant (GW679769) oral tablets<br>* Casopitant will be available in the dose strength of 20,30 or 50 mg<br>Drug: Warfarin oral tablets<br>* Warfarin will be available in the dose strength of 5 mg<br>* Other names: Casopitant (GW679769) oral tablets;|
| Experimental: Treatment regimen C<br>In treatment regimen C subject will co-administer warfarin and casopitant 30 mg/day for 14 days. | Drug: Casopitant (GW679769) oral tablets<br>* Casopitant will be available in the dose strength of 20,30 or 50 mg<br>Drug: Warfarin oral tablets<br>* Warfarin will be available in the dose strength of 5 mg<br>* Other names: Casopitant (GW679769) oral tablets;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma levels of Warfarin at Period 1: Day 9 to 14, Period 2: Day 2 & 3 and Day 5 to 16. |  | Period 1: Day 9 to 14, Period 2: Day 2 & 3 and Day 5 to 16. | 
| Plasma levels of casopitant at Period 2: Day 2 & 3 and Day 5 to 16. |  | Period 2: Day 2 & 3 and Day 5 to 16. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical lab tests monitoring of International Normalized Ratio (INR) adverse events vital signs 12 lead ECGs liver function tests |  | throughout the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy human volunteer, GW679769, warfarin, casopitant