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

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.

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 Investigator: GlaxoSmithKline Industry

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, MD Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on February 12, 2012

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