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

August 8, 2017 updated by: GlaxoSmithKline

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32605
        • GSK Investigational Site
    • New York
      • Buffalo, New York, United States, 14202
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • Casopitant (GW679769) oral tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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.
Time Frame: Period 2: Day 2 & 3 and Day 5 to 16.
Period 2: Day 2 & 3 and Day 5 to 16.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2006

Primary Completion (ACTUAL)

March 18, 2007

Study Completion (ACTUAL)

March 18, 2007

Study Registration Dates

First Submitted

November 27, 2006

First Submitted That Met QC Criteria

November 27, 2006

First Posted (ESTIMATE)

November 28, 2006

Study Record Updates

Last Update Posted (ACTUAL)

August 9, 2017

Last Update Submitted That Met QC Criteria

August 8, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NKV105097

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Study Data/Documents

  1. Individual Participant Data Set
    Information identifier: NKV105097
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Dataset Specification
    Information identifier: NKV105097
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Informed Consent Form
    Information identifier: NKV105097
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Study Protocol
    Information identifier: NKV105097
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Annotated Case Report Form
    Information identifier: NKV105097
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Clinical Study Report
    Information identifier: NKV105097
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Statistical Analysis Plan
    Information identifier: NKV105097
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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