Absolute Bioavailability study using IV tracer method

• Research type

  Research Study

• Full title

  An Absolute Bioavailability Study of LY2140023 and LY404039 in Healthy Subjects Using the Intravenous Tracer Method

• IRAS ID

  89815

• Contact name

  Ashley Brooks

• Sponsor organisation

  Eli Lilly and company

• Eudract number

  2011-002543-10

• Research summary

  Eli Lilly and Company is currently developing LY2140023 as a treatment for schizophrenia. LY2140023 is a methionine pro drug which is broken down in the body to form LY404039, which is active in humans. LY2140023 utilises 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.This is an open label, 2 period, fixed sequence, single center, crossover study, with inpatient dosing. All subjects will receive the following 2 treatments in a fixed order, with a washout period of at least 3 days between treatments:Period 1: Subjects will receive an oral dose of 80 mg LY2140023 and a 2 hour IV infusion of 100 microgram LY2140023 containing radiolabelled LY2140023 starting at the time of the oral dose of LY2140023. Period 2: Subjects will receive an oral dose of 80 mg LY2140023 and a 2 hour IV infusion of 100 microgram LY404039 containing radiolabelled LY404039 starting at the time of the oral dose of LY2140023.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/IE/0164

• Date of REC Opinion

  28 Dec 2011

• REC opinion

  Further Information Favourable Opinion