Last updated: 11/04/2018 09:46:58

A Study to Assess the Safety & Interaction Between GW679769, Dexamethasone, & Ondansetron When Taken by Healthy Adults

GSK study ID
NKV100787
See study documents
Clinicaltrials.gov ID
NCT00437229
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, Phase I Study to Assess the Pharmacokinetic Interaction Between Repeat Doses of Oral Casopitant and Intravenous and Oral Doses of Dexamethasone and Intravenous and Oral Doses of Ondansetron when Administered in Healthy Adult Subjects
Trial description: GW679769 may affect liver enzymes that metabolize dexamethasone and ondansetron. This study is designed to test the safety and the extent of the GW679769 affect on dexamethasone and ondansetron levels in humans.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Part A: Period 1 & 2: Plasma levels of casopitant, dexamethasone, & ondansetron will be checked on Day 1, 2 and/or 3. Part B: Period 1, 2 & 3: Plasma levels of casopitant, dexamethasone, & ondansetron will be checked on Day 1, 2 and/or 3.

Timeframe: checked on Day 1, 2 and/or 3

Secondary outcomes:

Safety is evaluated by: Clinical Lab Tests done

Timeframe: at Screening, Day -1 & Followup.

Vitals Signs taken & Adverse Events monitored

Timeframe: at each visit starting at Day -1.

12 lead ECGs & Serum Pepsinogen level tests

Timeframe: at Screening & Followup.

Interventions:
  • Drug: Casopitant (GW679769) Oral Tablets
  • Drug: dexamethasone
  • Drug: ondansetron
    • Enrollment:
    37
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Johnson B, Adams L, Lu E, Zhang K, Lebowitz P, Lates C, Blum R. Impact of casopitant, a novel NK-1 receptor antagonist on the pharmacokinetics of ondansetron and dexamethasone. Support Care Cancer. 2009;17(9):1177-85.
    Medical condition
    Nausea and Vomiting, Chemotherapy-Induced
    Product
    casopitant, ondansetron
    Collaborators
    Not applicable
    Study date(s)
    February 2007 to May 2007
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 55 years
    Accepts healthy volunteers
    Yes
    • Healthy adult males or females
    • Age: 18 to 55 years, inclusive
    • Cannot participation if subject has a clinically relevant abnormality, medical condition, or circumstance that makes them unsuitable for the study per the study doctor.
    • History of drug or other allergy which, in the opinion of the Investigator, contraindicates participation.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Healthy adult males or females
    • Age: 18 to 55 years, inclusive
    • A female subject who is non-childbearing potential or using acceptable contraceptive methods.
    • Adequate organ systems function
    • Able to swallow and retain oral medication
    • Able to understand and comply with protocol requirements and instruction and is likely to complete the study.
    Exclusion criteria:
    • Cannot participation if subject has a clinically relevant abnormality, medical condition, or circumstance that makes them unsuitable for the study per the study doctor.
    • History of drug or other allergy which, in the opinion of the Investigator, contraindicates participation.
    • Use of an investigation drug within 28 days or 5 half-lives.
    • Blood donation in excess of 500mL within 56 days prior to dosing or intends to donate within 30 days of the post-treatment follow-up visit.
    • Presence of or suspected iron deficiency
    • Positive stool for occult blood
    • Female subject who is lactating
    • Positive urine drug screen
    • Positive for HIV antibody, hepatitis C antibody or hepatitis B surface antigen
    • Use of tobacco-containing products within the past 12 months prior to screening
    • History of drug or alcohol abuse or dependence within 6 months of screening
    • History or presence of uncontrolled emesis
    • Positive purified protein derivative (PPD) skin test for tuberculosis

    Trial location(s)

    Location
    Status
    Contact us
    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
    2007-15-05

    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

    Participate in clinical trial
    Additional information
    Results for study 100787 can be found on the GSK Clinical Study Register.
    Click here
    Access to clinical trial data by researchers
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