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

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ClinicalTrials.gov Identifier: NCT00404274
Recruitment Status : Completed
First Posted : November 28, 2006
Last Update Posted : August 9, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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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.

Condition or disease Intervention/treatment Phase
Nausea and Vomiting, Chemotherapy-Induced Drug: Casopitant (GW679769) oral tablets Drug: Warfarin oral tablets Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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.
Actual Study Start Date : November 1, 2006
Actual Primary Completion Date : March 18, 2007
Actual Study Completion Date : March 18, 2007

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: Casopitant (GW679769) oral tablets
Casopitant will be available in the dose strength of 20,30 or 50 mg

Drug: Warfarin oral tablets
Warfarin will be available in the dose strength of 5 mg
Other Name: Casopitant (GW679769) oral tablets
Experimental: Treatment regimen B
In treatment regimen B subject will co-administer casopitant 60 mg/day and warfarin for 14 days.
 Drug: Casopitant (GW679769) oral tablets
Casopitant will be available in the dose strength of 20,30 or 50 mg

Drug: Warfarin oral tablets
Warfarin will be available in the dose strength of 5 mg
Other Name: Casopitant (GW679769) oral tablets
Experimental: Treatment regimen C
In treatment regimen C subject will co-administer warfarin and casopitant 30 mg/day for 14 days.
 Drug: Casopitant (GW679769) oral tablets
Casopitant will be available in the dose strength of 20,30 or 50 mg

Drug: Warfarin oral tablets
Warfarin will be available in the dose strength of 5 mg
Other Name: Casopitant (GW679769) oral tablets


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]
  2. 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 Measures :
  1. Clinical lab tests monitoring of International Normalized Ratio (INR) adverse events vital signs 12 lead ECGs liver function tests [ Time Frame: throughout the study ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00404274


Locations
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United States, Florida
GSK Investigational Site
Gainesville, Florida, United States, 32605
United States, New York
GSK Investigational Site
Buffalo, New York, United States, 14202
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Additional Information:
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.  This link exits the ClinicalTrials.gov site Results for study NKV105097 can be found on the GSK Clinical Study Register.  This link exits the ClinicalTrials.gov site

Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: NKV105097
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: NKV105097
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: NKV105097
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: NKV105097
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: NKV105097
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: NKV105097
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: NKV105097
For additional information about this study please refer to the GSK Clinical Study Register

Publications of Results:

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00404274     History of Changes
Other Study ID Numbers: NKV105097
First Posted: November 28, 2006    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Keywords provided by GlaxoSmithKline:
healthy human volunteer
GW679769
warfarin
casopitant
Additional relevant MeSH terms:
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Warfarin
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Casopitant
Anticoagulants
Antiemetics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action