Clinical trial NCT00404274: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Nausea and Vomiting, Chemotherapy-Induced
Keywords: healthy human volunteer
GW679769
warfarin
casopitant
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-11-28
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.


Eligibility 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

Primary outcomes:
measure: Plasma levels of Warfarin at Period 1: Day 9 to 14, Period 2: Day 2 & 3 and Day 5 to 16.
timeFrame: Period 1: Day 9 to 14, Period 2: Day 2 & 3 and Day 5 to 16.
measure: Plasma levels of casopitant at Period 2: Day 2 & 3 and Day 5 to 16.
timeFrame: Period 2: Day 2 & 3 and Day 5 to 16.
Secondary outcomes:
measure: Clinical lab tests monitoring of International Normalized Ratio (INR) adverse events vital signs 12 lead ECGs liver function tests
timeFrame: throughout the study
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: GSK Investigational Site
state: Florida
city: Buffalo
country: United States
facility: GSK Investigational Site
state: New York
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.