Last updated: 11/04/2018 09:50:27

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

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GSK study ID
NKV105097
See study documents
Clinicaltrials.gov ID
NCT00404274
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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.
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Plasma levels of Warfarin at Period 1: Day 9 to 14, Period 2: Day 2 & 3 and Day 5 to 16.

Timeframe: 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.

Timeframe: Period 2: Day 2 & 3 and Day 5 to 16.

Secondary outcomes:

Clinical lab tests monitoring of International Normalized Ratio (INR) adverse events vital signs 12 lead ECGs liver function tests

Timeframe: throughout the study

Interventions:
  • Drug: Casopitant (GW679769) oral tablets
  • Drug: Warfarin oral tablets
    • Enrollment:
    97
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Kirby LC; Johnson BM; Adamns 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):566-575
    Kirby LC; Johnson BM; Adamns 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):566-575
    Medical condition
    Nausea and Vomiting, Chemotherapy-Induced
    Product
    casopitant
    Collaborators
    Not applicable
    Study date(s)
    November 2006 to March 2007
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    Yes
    • Inclusion criteria:
    • Healthy subjects
    Inclusion and exclusion criteria
    Inclusion 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

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Gainesville, Florida, United States, 32605
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Buffalo, New York, United States, 14202
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2007-18-03

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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    Additional information
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