Effect of single doses MT-8554 with pain stimulus in healthy subjects

• Research type

  Research Study

• Full title

  A randomized, double-blind, double-dummy, placebo-controlled, crossover study to investigate the pharmacodynamic effect of single doses of MT-8554 on response to pain stimulus in the cold pressor test in healthy male Caucasian subjects

• IRAS ID

  179743

• Contact name

  Annelize Koch

• Contact email

  annelize.koch@parexel.com

• Sponsor organisation

  Mitsubishi Tanabe Pharma Europe Ltd.

• Eudract number

  2015-001185-26

• Clinicaltrials.gov Identifier

  222444, PAREXEL study number

• Duration of Study in the UK

  0 years, 2 months, 16 days

• Research summary

  This is a Phase I, randomized, double-blind, double-dummy, placebo-controlled, crossover, single-centre study. A total of 20 healthy male Caucasian subjects aged 18-55 years who neet the study criteria will be randomized in the study. The new medicine tested (MT-8554) is developed for the treatment of neuropathic pain and pain-related indications. This study consists of 2 screening visits, 4 treatment periods and 1 follow-up visit. For each treatment period the subjects will be admitted to the clinical unit the day before first dosing with the study drug (Day -1) and be required to stay in the unit for 4 days and 3 nights. Subject will be dosed on Day 1 of each treatment period with one of 4 treatment regimens and have assessments performed until 48 hours after dosing. Part of the assessment includes the Cold Pressor Test (CPT) which measures a subjects pain response to having their hand placed in cold water. Subjects will be discharged on Day 3 of each treatment period. The washout period between treatment periods is at least 6 days. A Follow-up Visit will take place 6 days after dosing in the the last treatment period.
  The 20 eligible subjects will receive MT-8554 (2 dose levels), oxycodone and placebo in a randomized order across the 4 treatment periods

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  15/SC/0250

• Date of REC Opinion

  21 Jul 2015

• REC opinion

  Further Information Favourable Opinion