Study comparing 3 different particle sizes to reference

  • Research type

    Research Study

  • Full title

    A Particle Size Study of 3 Different Particle Size Test Tablet Formulations Compared to the Reference Tablet Formulation in Healthy Subjects

  • IRAS ID

    97513

  • Contact name

    Ashley Brooks

  • Sponsor organisation

    Eli Lilly and Company

  • Eudract number

    2012-000096-17

  • ISRCTN Number

    n/a

  • Clinicaltrials.gov Identifier

    n/a

  • Research summary

    Eli Lilly and Company is currently developing LY2140023 as a treatment for schizophrenia. LY2140023 is the methionine prodrug of the mGlu2/3 receptor agonist LY404039. LY2140023 has been developed to enhance oral bioavailability of LY404039, the active metabolite, in humans. LY2140023 utilizes endogenous peptide absorption and metabolic pathways to efficiently deliver LY404039 to the systemic circulation. This study will evaluate the relative bioavailability of 3 test tablet formulations of LY2140023, with different particle sizes, compared to the reference tablet formulation which has been used in Phase 2 and Phase 3 studies. The test formulations of LY2140023 monohydrate to be evaluated will be called, test-low, test-medium, and test-high and will have target particle diameters in the approximate ranges of 30 - 40 micrometres, 70 - 85 micrometres, and 86 - 100 micrometres respectively. This will be an open-label, 4 period, 4 sequence, 4 treatment, randomized, crossover study conducted in up to 18 healthy male and female subjects. Subjects will receive single oral doses of 80 mg LY2140023 administered in the fed state (with standard light breakfast) on 4 separate occasions. Subjects will be randomly allocated to one of the treatment sequences shown in the table below. On each treatment period a different formulation of LY2140023 will be administered: Sequence Period 1 Period 2 Period 3 Period 4 1 Reference Test-low Test-medium Test-high 2 Test-low Test high Reference Test-medium 3 Test-high Test-medium Test-low Reference 4 Test-medium Reference Test-high Test-low In each treatment period, subjects will be admitted on Day 1 and discharged on Day 2. LY2140023 will be administered on Day 1. There will be at least a 3-day washout between dosing in one period and dosing in the next. Subjects will be followed up 3 to 7 days after dosing in Period 4. Relative bioavailability will be assessed through analysis of pharmacokinetic data.

  • REC name

    South Central - Berkshire B Research Ethics Committee

  • REC reference

    12/SC/0096

  • Date of REC Opinion

    19 Mar 2012

  • REC opinion

    Favourable Opinion