Last updated: 11/07/2018 07:29:29

A Study to Assess the Relative Bioavailability of Four New Formulations of GSK1605786 in Healthy Subjects

GSK study ID
114203
Clinicaltrials.gov ID
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: A Single Dose, Randomized, Five-Period Crossover Study to Assess the Relative Bioavailability of Four New Formulations of the CCR9 Receptor Antagonist GSK1605786A (CCX282) in Healthy Male and Female Subjects
Trial description: This is an open-label, single dose, randomized, five-period, crossover study in healthy volunteers to assess the relative bioavailability of four GSK developed oral formulations of GSK1605786 relative to the capsule formulation administered in the ChemoCentryx Phase IIb, PROTECT-1 Study and ChemoCentryx Thorough QT/QTc Study.
Approximately 24 subjects will be randomized to receive a single 500 mg dose of each of the five formulations of GSK1605786 after a standard breakfast. Serial pharmacokinetic samples will be collected following each dose and safety assessments will be performed. The relative bioavailability of the GSK capsule formulation will be compared to the ChemoCentryx formulation while the relative bioavailability the three other formulations will be compared to the GSK capsule formulation intended for use in a GlaxoSmithKline Phase IIb study.
Primary purpose:
Basic Science
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Plasma GSK1605786 parameters: AUC(0-∞), AUC(0-t), Cmax.

Timeframe: 2-4 weeks after the last subject last visit

Secondary outcomes:

Plasma GSK1605786 parameters: AUC(0-24), %AUCex, tlag, tmax, t1/2

Timeframe: 2-4 weeks after the last subject last visit

Safety and tolerability parameters including vital signs, ECGs, clinical laboratory

Timeframe: Results will be monitered in real time from screening through to the follow-up visit

Interventions:
  • Drug: GSK1605786 ChemoCentryx: formulation A
  • Drug: GSK1605786 GSK: formulation B
  • Drug: GSK1605786 GSK direct-fill: formulation C
  • Drug: GSK1605786 GSK modified-process: formulation D
  • Drug: GSK1605786 GSK tablet: formulation E
  • Enrollment:
    24
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Lynda Haberer, Hiroko Ino, Kim Hacquoil, Takashi Sakamoto, Noriaki Kanemoto, Iain McSherry, Toshiyasu Hirama . Single-dose pharmacokinetics of the CCR9 receptor antagonist, vercirnon in healthy US and Japanese subjects. Clin Pharmacol Drug Devel. 2013;2(4):387-393.
    Medical condition
    Crohn's Disease
    Product
    vercirnon
    Collaborators
    Not applicable
    Study date(s)
    May 2010 to June 2010
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 55 years
    Accepts healthy volunteers
    Yes
    • 1. AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
    • 2. Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and ECG. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
    • 1. A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
    • 2. Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Buffalo, New York, United States, 14202
    Status
    Study Complete

    Study documents

    Scientific result summary
    Available language(s): English

    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
    2010-29-06

    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 114203 can be found on the GSK Clinical Study Register.
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