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

Phase 1

Completed

• Conditions: Nausea and Vomiting, Chemotherapy-Induced
• Interventions: Drug: Casopitant (GW679769) oral tablets; Drug: Warfarin oral tablets

• Registration Number: NCT00404274
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-01
• Study First Submitted: 2006-11-27
• Study First Submitted QC: 2006-11-27
• Study First Posted: 2006-11-28
• Primary Completion: 2007-03-18
• Study Completion: 2007-03-18
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-08
• Last Update Posted: 2017-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment regimen C	Casopitant (GW679769) oral tablets	In treatment regimen C subject will co-administer warfarin and casopitant 30 mg/day for 14 days.
Treatment regimen A	Warfarin oral tablets	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.
Treatment regimen B	Warfarin oral tablets	In treatment regimen B subject will co-administer casopitant 60 mg/day and warfarin for 14 days.
Treatment regimen B	Casopitant (GW679769) oral tablets	In treatment regimen B subject will co-administer casopitant 60 mg/day and warfarin for 14 days.
Treatment regimen C	Warfarin oral tablets	In treatment regimen C subject will co-administer warfarin and casopitant 30 mg/day for 14 days.
Treatment regimen A	Casopitant (GW679769) oral tablets	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Buffalo, New York, United States