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

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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00404274

Enrollment

Registered

2006-11-28

Start date

2006-11-01

Completion date

2007-03-18

Last updated

2017-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nausea and Vomiting, Chemotherapy-Induced

Keywords

healthy human volunteer, GW679769, warfarin, casopitant

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.

Interventions

DRUGCasopitant (GW679769) oral tablets

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

DRUGWarfarin oral tablets

Warfarin will be available in the dose strength of 5 mg

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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.
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

Measure	Time frame
Clinical lab tests monitoring of International Normalized Ratio (INR) adverse events vital signs 12 lead ECGs liver function tests	throughout the study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026