ADME and absolute bioavailability of ITI-007 (QCL117219)

• Research type

  Research Study

• Full title

  ****************DEFERRAL REQUESTED************************\n\nA Phase I, Open-Label Study of the Absorption, Metabolism, Excretion and the Absolute Bioavailability of ITI-007 in Healthy Male Subjects

• IRAS ID

  182575

• Contact name

  Kimberly Vanover

• Sponsor organisation

  Intra-Cellular Therapies Inc

• Eudract number

  2015-001846-27

• Duration of Study in the UK

  0 years, 1 months, 14 days

• Research summary

  The Sponsor is developing the study drug, ITI-007, for the potential treatment of schizophrenia (a mental disorder) and other psychiatric and neurological disorders (mental illness), including but not limited to sleep maintenance disorders, depression and mania (abnormally elevated mood) in bipolar disorders, major depressive disorder, behavioural disturbances associated with neurological disorders including dementia and autism, intermittent explosive disorder (explosive outbursts of anger) and posttraumatic stress disorder.\n\nThe study will try to identify absolute bioavailability of a capsule formulation of the study drug. The study will also assess the rates and routes of excretion of the study drug following administration as a solution. How the body affects the study drug will be assessed in oral and intravenous formulations. The total radioactivity, study drug metabolite profiling and identification of potential metabolites will also be evaluated.\n\nThe study will consist of 2 parts involving up to 6 healthy males. Subjects will receive the following 3 regimens:\nPart 1\n•\tRegimen A: a single oral dose of 40 mg ITI-007 as 2 × 20 mg capsules, plus\n•\tRegimen B: an IV dose of [14C]-ITI-007 (40 μg) containing NMT 37 kBq (1000 nCi) 14C, administered 45 min post-administration of the single oral dose (Regimen A) as a 15 min IV infusion ending at approximately 1 h post oral dose (the time of maximum plasma concentration [Tmax] for the oral dose)\n\nPart 2\n•\tRegimen C: a single oral dose of 40 mg [14C]-ITI-007 as a solution containing NMT 1.96 MBq (53 μCi ) 14C\n

• REC name

  Wales REC 1

• REC reference

  15/WA/0215

• Date of REC Opinion

  16 Jul 2015

• REC opinion

  Further Information Favourable Opinion