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

This study has been completed.

First Received: November 27, 2006 Last Updated: May 15, 2009 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00404274

Purpose

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.

Condition	Intervention	Phase
Healthy Subjects	Drug: Casopitant (GW679769) oral tablets Drug: Warfarin oral tablets	Phase I

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

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners

Drug Information available for: Warfarin Casopitant Casopitant mesylate GW679769 Warfarin sodium Warfarin potassium

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome 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 Outcome 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 ]

Enrollment:	72
Study Start Date:	November 2006

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404274

Locations

United States, Florida
GSK Investigational Site
Gainesville, Florida, United States, 32605
United States, New York
GSK Investigational Site
Buffalo, New York, United States, 14202

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	NKV105097
Study First Received:	November 27, 2006
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00404274 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

healthy human volunteer
casopitant
warfarin
GW679769

Additional relevant MeSH terms:

Anticoagulants
Therapeutic Uses
Hematologic Agents
Warfarin
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010