Back to resultsA Study Testing the Effect and Safety of Casopitant (GW679769) While Taking Warfarin in Healthy Human Volunteers
Primary Purpose
Nausea and Vomiting, Chemotherapy-Induced
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Casopitant (GW679769) oral tablets
Warfarin oral tablets
Sponsored by
About this trial
This is an interventional prevention trial for Nausea and Vomiting, Chemotherapy-Induced focused on measuring healthy human volunteer, GW679769, warfarin, casopitant
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
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Treatment regimen A
Treatment regimen B
Treatment regimen C
Arm Description
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.
In treatment regimen B subject will co-administer casopitant 60 mg/day and warfarin for 14 days.
In treatment regimen C subject will co-administer warfarin and casopitant 30 mg/day for 14 days.
Outcomes
Primary Outcome Measures
Plasma levels of Warfarin at 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.
Secondary Outcome Measures
Clinical lab tests monitoring of International Normalized Ratio (INR) adverse events vital signs 12 lead ECGs liver function tests
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00404274
Brief Title
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
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
November 1, 2006 (Actual)
Primary Completion Date
March 18, 2007 (Actual)
Study Completion Date
March 18, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea and Vomiting, Chemotherapy-Induced
Keywords
healthy human volunteer, GW679769, warfarin, casopitant
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment regimen A
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment regimen B
Arm Type
Experimental
Arm Description
In treatment regimen B subject will co-administer casopitant 60 mg/day and warfarin for 14 days.
Arm Title
Treatment regimen C
Arm Type
Experimental
Arm Description
In treatment regimen C subject will co-administer warfarin and casopitant 30 mg/day for 14 days.
Intervention Type
Drug
Intervention Name(s)
Casopitant (GW679769) oral tablets
Intervention Description
Casopitant will be available in the dose strength of 20,30 or 50 mg
Intervention Type
Drug
Intervention Name(s)
Warfarin oral tablets
Other Intervention Name(s)
Casopitant (GW679769) oral tablets
Intervention Description
Warfarin will be available in the dose strength of 5 mg
Primary Outcome Measure Information:
Title
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.
Title
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 Measure Information:
Title
Clinical lab tests monitoring of International Normalized Ratio (INR) adverse events vital signs 12 lead ECGs liver function tests
Time Frame
throughout the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
GSK Investigational Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Citations:
PubMed Identifier
20220045
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.
Results Reference
result
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
NKV105097
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
NKV105097
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
NKV105097
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
NKV105097
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
NKV105097
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
NKV105097
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
NKV105097
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
A Study Testing the Effect and Safety of Casopitant (GW679769) While Taking Warfarin in Healthy Human Volunteers
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