A Study Testing the Effect and Safety of Casopitant (GW679769) While Taking Warfarin in Healthy Human Volunteers
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Casopitant (GW679769) oral tablets (Drug); Warfarin oral tablets (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Chair, Affiliation: GlaxoSmithKline
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.
Clinical Details
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.
Study design: Prevention, Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: Plasma levels of Warfarin at 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.
Secondary outcome: Clinical lab tests
monitoring of International Normalized Ratio (INR)
adverse events
vital signs
12 lead ECGs
liver function tests
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
GSK Clinical Trials Call Center, Gainesville, Florida 32605, United States
GSK Clinical Trials Call Center, Buffalo, New York 14209, United States
Additional Information
Starting date: November 2006
Last updated: September 7, 2007
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