Last updated: 11/04/2018 06:06:34

A Study Of GW406381 In Volunteers With Moderate Hepatic Impairment

GSK study ID
CXA100754
See study documents
Clinicaltrials.gov ID
NCT00373243
EudraCT ID
2004-004659-21
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-randomised study of 20 mg GW406381 single dose pharmacokinetics in healthy subjects and in volunteers with moderate hepatic impairment
Trial description: This study will assess the pharmacokinetics and tolerability of a single dose of GW406381 in subjects with moderate hepatic impairment in comparison to matched healthy volunteers. The hepatically impaired and healthy groups will be given a single 20 mg oral dose of GW406381. Blood samples for PK analysis will be collected pre-dose and over the 72 hours post dosing. Subjects will be housed from the evening before dosing until 24 hours after dosing. A follow-up visit will be conducted between 7 to 10 days from the last dose of study drug.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

GW406381 pharmacokinetic parameters AUC and Cmax

Timeframe: throughout the study

Secondary outcomes:

GW406381 pharmacokinetic parameters Tmax, Total plasma clearance, and if data permits the t1/2 of GW406381 GW404347 pharmacokinetic parameters AUC and Cmax Ex vivo protein binding Clinical laboratory values, adverse events, vital signs and 12 lead ECG

Timeframe: throughout the study

Interventions:
  • Drug: GW406381
    • Enrollment:
    24
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Pain
    Product
    GW406381
    Collaborators
    Not applicable
    Study date(s)
    October 2005 to September 2006
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    Yes
    • Inclusion criteria:
    • Healthy subjects or subjects with moderate hepatic impairment as defined by a Child-Pugh score of 7-9
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Healthy subjects or subjects with moderate hepatic impairment as defined by a Child-Pugh score of 7-9
    • Body weight less = 100 kg
    • Body mass index (BMI) within range of 19 – 32 32kg/m2 Exclusion criteria:
    • Presence of any other significant disease
    • Use of any medication within the 2 weeks prior to dosing, unless approved by both the investigator and GSK personnel

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Budapest, Hungary, 1062
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Balantonfured, Hungary, 8230
    Status
    Study Complete
    Contact us

    Study documents

    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
    2006-26-09

    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 CXA100754 can be found on the GSK Clinical Study Register.
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