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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-01

Study Completion Date

2007-03-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Nausea and Vomiting, Chemotherapy-Induced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Treatment regimen A

In treatment regimen A subject will co-administer casopitant and warfarin over three-day period (Day 1 150 milligram per day \[mg/day\], Day 2 50 mg/day, Day 3 50 mg/day) and from Days 4 to 10 subject will administer only warfarin.

Group Type EXPERIMENTAL

Casopitant (GW679769) oral tablets

Intervention Type DRUG

Casopitant will be available in the dose strength of 20,30 or 50 mg

Warfarin oral tablets

Intervention Type DRUG

Warfarin will be available in the dose strength of 5 mg

Treatment regimen B

In treatment regimen B subject will co-administer casopitant 60 mg/day and warfarin for 14 days.

Group Type EXPERIMENTAL

Casopitant (GW679769) oral tablets

Intervention Type DRUG

Casopitant will be available in the dose strength of 20,30 or 50 mg

Warfarin oral tablets

Intervention Type DRUG

Warfarin will be available in the dose strength of 5 mg

Treatment regimen C

In treatment regimen C subject will co-administer warfarin and casopitant 30 mg/day for 14 days.

Group Type EXPERIMENTAL

Casopitant (GW679769) oral tablets

Intervention Type DRUG

Casopitant will be available in the dose strength of 20,30 or 50 mg

Warfarin oral tablets

Intervention Type DRUG

Warfarin will be available in the dose strength of 5 mg

Interventions

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Casopitant (GW679769) oral tablets

Casopitant will be available in the dose strength of 20,30 or 50 mg

Intervention Type DRUG

Warfarin oral tablets

Warfarin will be available in the dose strength of 5 mg

Intervention Type DRUG

Other Intervention Names

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Casopitant (GW679769) oral tablets

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Gainesville, Florida, United States

Site Status

GSK Investigational Site

Buffalo, New York, United States

Site Status

Countries

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United States

References

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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):566-75. doi: 10.1177/0091270009346965. Epub 2010 Mar 10.

Reference Type RESULT

PMID: 20220045 (View on PubMed)

Study Documents

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