Last updated: 11/03/2018 16:14:27

Healthy volunteer pilot study using 3 types of modified release formulations of firategrast to investigate how quickly absorption from the digestive system takes place.

GSK study ID
114107
See study documents
Clinicaltrials.gov ID
NCT01424462
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, randomised healthy volunteer study to assess the single dose safety and pharmacokinetics of three modified release dosage forms of firategrast
Trial description: This study will investigate how 3 new types of drug formulations are absorbed by the body. This study is termed 'open-label', which means volunteers will be aware of which treatment they are receiving. The study involves all volunteers receiving all 3 different formulations, as a single dose, and there is no placebo (dummy-drug; no active ingredient) in this study. Volunteers will also receive a single dose of a formulation used in previous trials (reference formulation), so as a proper comparison with the new formulations can be made. One of the new formulations will also be administered along with food, to assess if the drug performs or is absorbed differently.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Systemic concentration & AUC of study drug

Timeframe: pre-dose, up to 120 hours after each single dose

Secondary outcomes:

Adverse events

Timeframe: from screening, through study day, and up to follow-up visit. Spontaneous reporting

Systemic concentration & AUC of study drug metabolite

Timeframe: pre-dose, up to 120 hours after each single dose

Vital signs

Timeframe: screening, pre-dose, up-to 15 hours post does, follow-up visit

12-lead Electrocardiogram

Timeframe: screening, pre-dose and up to 8 hours post dose, then at follow-up

Heamatology, clinical chemistry and Uninalysis

Timeframe: screening, predose, up-to 8 hours post dose, follow-up

Interventions:
  • Drug: A
  • Drug: B
  • Drug: C
  • Drug: D
    • Enrollment:
    20
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Multiple Sclerosis, Relapsing-Remitting
    Product
    firategrast
    Collaborators
    Not applicable
    Study date(s)
    April 2010 to July 2010
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    Yes
    • Male or female, aged 18 to 65 yrs inclusive
    • Healthy, as determined by study physician
    • Positive drugs of abuse result
    • Positive for HIV or Hepatitis B and/or C viruses
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Male or female, aged 18 to 65 yrs inclusive
    • Healthy, as determined by study physician
    • Capable of giving informed consent
    Exclusion criteria:
    • Positive drugs of abuse result
    • Positive for HIV or Hepatitis B and/or C viruses
    • History of alcohol consumption in excess of average recommended weekly intake (more than 21 units for males, more than 14 units for females)
    • Participation in a clinical trial within 90 days of scheduled first dose

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Randwick, New South Wales, Australia, 2031
    Status
    Will Be Recruiting
    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
    2010-06-07

    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 114107 can be found on the GSK Clinical Study Register.
    Click here
    Access to clinical trial data by researchers
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