Impact of Variations in Urinary pH on the PK of LY2140023 and LY404039

• Research type

  Research Study

• Full title

  Impact of Variations in Urinary pH on the Pharmacokinetics of LY2140023 and LY404039 in Healthy Subjects

• IRAS ID

  82805

• Sponsor organisation

  Eli Lilly and company

• Eudract number

  2011-003215-36

• Research summary

  Eli Lilly and Company is currently developing LY2140023 as a treatment for Schizophrenia. LY2140023 is a methionine prodrug which is broken down in the body to a more potent form LY404039 which is active in humans. LY2140023 utilizes certain absorption and metabolic pathways to efficiently deliver the active form of the drug into the body's circulation. LY2140023 acts as a metabotropic glutamate 2/3 receptor agonist. The purpose of this study is to determine how the urinary pH variations affects the way LY2140023, and its active form LY404039, is broken down in the body after administration of a single 80 mg oral dose of LY2140023. Ammonium chloride will be administered to acidify the urine and sodium carbonate will be administered to alkalinize the urine. This is an open label study taking place over 3 treatment periods in which subjects will crossover to the different treatment arms. This study drug will be tested in healthy males and female subjects. A single 80 mg dose of LY2140023 will be administered alone and in combination with ammonium chloride or sodium bicarbonate. All subjects will receive the treatments in a random order (like flipping a coin).

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/IE/0117

• Date of REC Opinion

  21 Jul 2011

• REC opinion

  Favourable Opinion