Last updated: 11/04/2018 06:47:42

Investigating The Pharmacokinetics Of An Inhaled Dose Of A New Corticosteroid In Patients With Impaired Liver Function

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GSK study ID
FFA10013
See study documents
Clinicaltrials.gov ID
NCT00419237
EudraCT ID
2004-002363-25
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: A study to investigate the pharmacokinetics of a single inhaled dose (400mcg) of GW685698X and its effect on serum cortisol in patients with impaired liver function and matched control subjects.
Trial description: The proposed study is designed to investigate the pharmacokinetics, pharmacodynamics (as measured by serum cortisol) and safety of GW685698X in subjects with moderate hepatic impairment and in healthy subjects following a single oral inhaled dose of GW685698X. From the study results it should be possible to assess if there is an altered Risk: Benefit in patients with moderate hepatic impairment
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

To investigate how impaired liver function affects the movement of single dose inhaled drug GW685698X within the body. Blood exposure levels in patients and matched control patients compared by taking blood samples after dosing

Timeframe: Up to Day 13

Secondary outcomes:

Effect of GW685698X on serum cortisol by calculating weighted mean in blood over 24 hrs. Safety and tolerability of GW685698X in patients with impaired liver function from blood samples during dosing (clearance/distribution) and monitoring vital signs

Timeframe: Up to Day 13

Interventions:
  • Drug: GW685698X
    • Enrollment:
    20
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Asthma
    Product
    fluticasone furoate
    Collaborators
    Not applicable
    Study date(s)
    January 2005 to April 2005
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 70 years
    Accepts healthy volunteers
    Yes
    • Inclusion:
    • Are aged between 18-70 years, inclusive.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion:
    • Are aged between 18-70 years, inclusive.
    • If Female, you must be incapable of becoming pregnant.
    • Show FEV1 of more than 70% of the predicted normal at screening.
    • Are able to correctly use a DISKUS at the screening visit.
    • Have Body Mass Index within the range of 19-33 kg/m2 inclusive.
    • Do not show a positive pre-study urine drug screen.
    • Do not show a positive pre-study blood alcohol test.
    • Demonstrate a clinically normal 12-lead ECG at screening.
    • Do not show a positive blood test for HIV. If you are a Healthy Volunteer you must also:
    • Have no significant abnormality on clinical examination.
    • Have Liver Function Tests within the reference range at screening. If you are a Patient Volunteer you must:
    • Have moderate hepatic impairment
    • Have no significant abnormality on clinical examination apart from hepatic impairment. Exclusion:
    • Suffered an upper respiratory infection in the 4 weeks before the screening visit.
    • Suffered a lower respiratory infection in the 6 weeks before the screening visit.
    • Taken oral corticosteroids in the 8 weeks before the screening visit.
    • Taken inhaled, intranasal or topical steroids in the 4 weeks before the screening visit.
    • A prolonged heartbeat (QTc interval >470msec).
    • High blood pressure (systolic >160mmHg or diastolic >90mmHg) or as defined by the Investigator.
    • Known sensitivity to corticosteroids.
    • A history of lactose intolerance.
    • A history of severe milk protein allergy.
    • Donated blood in the last 3 months, or more than 1500mL (1000mL if female) in the last 12 months (including the amount taken for this study).
    • Participated in a clinical trial within the last 3 months where you are/were exposed to a drug or device.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    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
    2005-15-04

    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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