Last updated: 11/04/2018 09:49:17

A Study in Healthy Subjects to Assess How Dosing of Rifampin Affects What the Body Does to a Dose of GW679769 (Casopitant).

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GSK study ID
NKV105091
See study documents
Clinicaltrials.gov ID
NCT00405080
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, Two Period, Fixed Sequence Study of Healthy Subjects to Assess the Effect of Repeat Oral Dosing of [Rifampin] on the Pharmacokinetics of a Single Oral Dose of [GW679769]
Trial description: This study will examine what the body does while taking GW679769 alone and together with rifampin in healthy adult subjects.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Plasma levels for casopitant will be measured in Period 1 at Day 1 to 3 and in Period 2 at Day 8. Plasma levels for rifampin will be measured in Period 2 at Day 8 to 10.

Timeframe: Up to Day 10

Secondary outcomes:

clinical lab tests adverse events vital signs 12 lead ECGs liver function tests

Timeframe: Up to Day 12

Interventions:
  • Drug: GW679769 (Casopitant) oral tablets
  • Drug: Rifampin oral capsules
    • Enrollment:
    12
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Nausea and Vomiting, Chemotherapy-Induced
    Product
    casopitant
    Collaborators
    Not applicable
    Study date(s)
    November 2006 to January 2007
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 55 years
    Accepts healthy volunteers
    Yes
    • Inclusion criteria:
    • healthy
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • healthy
    • female subjects who cannot become pregnant
    • able to swallow and keep down oral medication
    • can understand and follow the protocol requirements and instructions Exclusion criteria:
    • smokes at least 4 packs per day in the past 12 months
    • use of prescription or non-prescription drug(s)
    • herbal or dietary supplements or vitamins with 14 days prior to first dose of study medication
    • a clinically relevant abnormality medical condition or circumstance making the subject unsuitable for the study per the study doctor
    • blood donation in excess of 1 pint within 56 days before dosing of medication
    • iron deficient
    • history or drug allergy of study medication
    • 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
    • active peptic ulcer disease
    • uncontrolled nausea and vomiting
    • active infection
    • heart failure
    • female who is lactating
    • female who has a positive pregnancy test

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Tacoma, Washington, United States, 98418
    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
    2007-05-01

    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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    Results for study NKV105091 can be found on the GSK Clinical Study Register.
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