Nausea and Vomiting, Chemotherapy-Induced Clinical Trial
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.
Verified date | August 2017 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 97 |
Est. completion date | March 18, 2007 |
Est. primary completion date | March 18, 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | GSK Investigational Site | Buffalo | New York |
United States | GSK Investigational Site | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
United States,
Kirby LC, Johnson BM, Adams LM, Eberwein DJ, Zhang K, Murray SC, Lates CD, Blum RA, Morris SR. Effect of casopitant, a novel NK-1 receptor antagonist, on the pharmacokinetics and pharmacodynamics of steady-state warfarin. J Clin Pharmacol. 2010 May;50(5): — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | ||
Primary | 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 | Clinical lab tests monitoring of International Normalized Ratio (INR) adverse events vital signs 12 lead ECGs liver function tests | throughout the study |
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