LY2979165 and LY2140023 on the Ketamine-Challenge PhMRI Assay

• Research type

  Research Study

• Full title

  Biomarker Study: Impact of Single Doses of LY2979165 and LY2140023 on the Ketamine-Challenge Pharmacological MRI Assay in Healthy Male Subjects

• IRAS ID

  89828

• Contact name

  Darren Wilbraham

• Sponsor organisation

  Lilly UK

• Eudract number

  2011-000058-50

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  LY2979165 is a drug that may be useful in the treatment of bipolar disorder and LY2140023 useful in the treatment of schizophrenia. Both mental disorders are thought to be caused by various chemical imbalances in the brain. They are lifelong conditions, which not only affect patients but also family and close friends. Approximately 44 healthy male volunteers will complete the trial, 12 in Part A and 32 in Part B. Part A will take place solely at Quintiles and Part B will take place at Quintiles and the Institute of Psychiatry, King's College London. This is not the first time that LY2979165 and LY2140023 will be administered to humans in clinical trials. The purpose of part A of this study is to examine the safety and tolerability of increasing single oral doses of LY2979165 or LY2140023 followed by intravenous administration of ketamine (a marketed drug) in healthy young volunteers. The purpose of part B of this study is to investigate whether different dose levels of LY2979165 or LY2140023, when administered by mouth, alter the effects of a ketamine infusion seen on brain imagery. This will enable doses to be selected for future patient studies. LY2979165 and LY2140023 are being developed by Eli Lilly and this study is being carried out on their behalf by Quintiles Drug Research Unit at Guy??s Hospital and the Institute of Psychiatry, King's College London.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  11/IE/0166

• Date of REC Opinion

  6 Dec 2011

• REC opinion

  Further Information Favourable Opinion