A Study to Assess the Relative Bioavailability of Four New Formulations of GSK1605786 in Healthy Subjects
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      This will be a randomized, open-label, single-dose, five-period, crossover study in healthy
      volunteers to compare the relative bioavailability of 5 oral GSK1605786 formulations.
      Recruitment/screening will occur within approximately 30 days of the first scheduled dose of
      study medication. Each subject will participate in five dosing sessions - each dose will be
      separated by at least seven days. The total duration of a subject's participation in the
      study, from Screening to Follow-up, is approximately 10 weeks.

      All subjects will receive single 500mg doses of the following five GSK1605786 formulations:
      A. ChemoCentryx formulation of GSK1605786; 2 x 250mg capsules [Formulation A] B. GSK
      formulation of GSK1605786; 2 x 250mg capsules [Formulation B] C. GSK direct-fill formulation
      of GSK1605786; 2 x 250mg capsules [Formulation C] D. GSK modified formulation of GSK1605786;
      2 x 250mg capsules [Formulation D] E. GSK tablet formulation of GSK1605786; 500mg tablet
      [Formulation E]

      Formulations A and B will administered in periods 1 and 2 in a random order, and formulations
      C, D and E will be administered in periods 3, 4, and 5 in a random order.

      Subjects will check into the clinical research unit (CRU) 1 day prior to dosing (Day -1). The
      study medication will be administered in the morning of Day 1 with 240 mL of water 30 minutes
      after a standard breakfast (i.e., fed state). For each treatment period, subjects will stay
      in the CRU through the 48-hour PK sample on the morning of Day 3. Subjects may be released
      from the clinic on Day 3 (after all required study procedures are completed) and return to
      the CRU that evening and the next morning for collection of the 60- and 72-hour PK samples.

      Upon completion of the last dosing period or early withdrawal, subjects will return to the
      clinic approximately seven days after the last dose of study medication for a follow up visit
      and be subsequently discharged from the study.

      The study will be conducted at one center.
    

Intervention name(s): GSK1605786 ChemoCentryx: formulation A; GSK1605786 GSK: formulation B; GSK1605786 GSK direct-fill: formulation C; GSK1605786 GSK modified-process: formulation D; GSK1605786 GSK tablet: formulation E
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): ChemoCentryx formulation A will be an opaque Swedish orange body, blue coloured capsule with size zero, administered 30 minutes after standard breakfast.; GSK1605786 formulation B will be an opaque Swedish orange body capsule with size 0, administered 30 minutes after standard breakfast.; GSK1605786 formulation C will be an opaque Swedish orange body capsule with size 1, administered 30 minutes after standard breakfast.; GSK1605786 formulation D will be an opaque Swedish orange body capsule with size 0, administered 30 minutes after standard breakfast.; GSK1605786 formulation D will be a pink coloured film coated tablet, administered 30 minutes after standard breakfast.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: GSK1605786; relative bioavailability; CCR9 receptor antagonist