Last updated: 11/07/2018 17:46:12

Observational Study Evaluating The Processing Or Breakdown Of GW679769 In Subjects With Hepatic Impairment

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GSK study ID
NKT102785
See study documents
Clinicaltrials.gov ID
NCT00359177
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, Non-Randomized, Pharmacokinetic and Safety Study of Multiple Oral Doses of GW679769 in subjects with Hepatic Impairment
Trial description: The purpose of the study is to evaluate how subjects with mild or moderate liver problems process or breakdown the study drug GW679769 in their bodies as compared to healthy subjects.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Area under the concentration-time curve (AUC) of single oral dose of GW679769 in healthy subjects

Timeframe: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours

AUC of multiple oral dose of GW679769 in healthy subjects

Timeframe: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours

AUC of single oral dose of GW679769 in subjects with mild and moderate hepatic impairment

Timeframe: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours

AUC of multiple oral dose of GW679769 in subjects with mild and moderate hepatic impairment

Timeframe: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours

Maximum observed concentration (Cmax) of single oral dose of GW679769 in healthy subjects

Timeframe: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours

Cmax of multiple oral dose of GW679769 in healthy subjects

Timeframe: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours

Cmax of single oral dose of GW679769 in subjects with mild and moderate hepatic impairment

Timeframe: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours

Cmax of multiple oral dose of GW679769 in subjects with mild and moderate hepatic impairment

Timeframe: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours

AUC of single oral dose of GSK525060 in healthy subjects

Timeframe: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours

AUC of multiple oral dose of GSK525060 in healthy subjects

Timeframe: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours

AUC of single oral dose of GSK525060 in subjects with mild and moderate hepatic impairment

Timeframe: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours

AUC of multiple oral dose of GSK525060 in subjects with mild and moderate hepatic impairment

Timeframe: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours

Cmax of single oral dose of GSK525060 in healthy subjects

Timeframe: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours

Cmax of multiple oral dose of GSK525060 in healthy subjects

Timeframe: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours

Cmax of single oral dose of GSK525060 in subjects with mild and moderate hepatic impairment

Timeframe: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours

Cmax of multiple oral dose of GSK525060 in subjects with mild and moderate hepatic impairment

Timeframe: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours

Secondary outcomes:
Not applicable
Interventions:
  • Drug: GW679769
    • Enrollment:
    24
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    John Bauman, Joyce Antal, Laurel Adams, Brendan Johnson, Sharon Murray, Bin Peng, Lyndon Kirby, Peter Lebovitz, Thomas Marbury, Suzanne Swan, Maria Gutierrez, Geraldine Bichier. Effect of Hepatic or Renal Impairment on the Pharmacokinetics of Casopitant, a NK-1 Receptor Antagonist, for the Prevention of Post-Operative or Chemotherapy-Induced Nausea and Vomiting. Invest New Drugs. 2012;30(2):662-671.
    Medical condition
    Vomiting
    Product
    casopitant
    Collaborators
    Not applicable
    Study date(s)
    December 2005 to October 2006
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    Yes
    • Inclusion criteria:
    • Healthy or have mild or moderate hepatic impairment
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Healthy or have mild or moderate hepatic impairment
    • Females: Non-childbearing (hysterectomy, bilateral oophorectomy, post-menopausal), childbearing (negative pregnancy test, abstinence, double-barrier contraception, vasectomized partner)
    • Negative for Hepatitis B and C(healthy subjects)
    • Negative drug, alcohol and HIV tests Exclusion criteria:
    • Fluctuating or rapidly deteriorating hepatic function or abnormal kidney function
    • Encephalopathy
    • Active peptic ulcer disease
    • Drug or alcohol abuse
    • Pregnant or lactating
    • Esophageal bleeding
    • Heart failure
    • Infection

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Gainesville, Florida, United States, 32608
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Orlando, Florida, United States, 32809
    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
    2006-12-10

    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
    Results for study NKT102785 can be found on the GSK Clinical Study Register.
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