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.”

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Open Label, Single Group Assignment, Pharmacokinetics/Dynamics Study

Intervention(s) in this Clinical Trial

• Drug: Casopitant (GW679769) oral tablets
• Drug: Warfarin oral tablets

Primary Measures

• Plasma levels of Warfarin at Period 1: Day 9 to 14, Period 2: Day 2 & 3 and Day 5 to 16.
  • Time Frame: 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.
  • Time Frame: Period 2: Day 2 & 3 and Day 5 to 16.
    

Secondary Measures

• Clinical lab tests monitoring of International Normalized Ratio (INR) adverse events vital signs 12 lead ECGs liver function tests
  • Time Frame: throughout the study
    

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, MD Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00404274

Study ID Number: NKV105097

ClinicalTrials.gov Identifier: NCT00404274

Health Authority: United States: Food and Drug Administration