To assess a safe supratherapeutic dose of TC-5214 and effect on QT/QTc

• Research type

  Research Study

• Full title

  A single-centre, randomised, double-blind, placebo controlled Phase I study in two parts: Part A to assess a safe and tolerable supratherapeutic dose of TC-5214 after single ascending oral doses in healthy male subjects, followed by Part B: A four-period double-dummy crossover study to investigate the effect of 2 single doses (therapeutic and supratherapeutic) of TC-5214 on the QT/QTc interval, compared to placebo, using moxifloxacin (Avelox®) as a positive control, in healthy male subjects

• IRAS ID

  78748

• Sponsor organisation

  AstraZeneca R&D

• Eudract number

  2010-023511-33

• ISRCTN Number

  xx

• Research summary

  Currently the available treatments for depression have a significant failure rate. Unfortunately, no alternatives have been proven to be effective in the management of the majority of these patients. Mecamylamine HCl (Inversine©) is a drug that was licensed in the United States for many decades for the treatment of severe high blood pressure. It is made up of two parts. These have been termed TC-5214 and TC-5213. In this study we will be administering only TC-5214. Approximately 64 healthy male volunteers will take part in the total trial 12 in Part A and 52 in Part B.TC-5214 is a drug that may be useful in the treatment of mood disorders such as depression. This is not the first time that TC-5214 will be administered to humans in clinical trials. However, the study will involve administering doses higher than previous studies.The purpose of this research study is in Part A, to evaluate safety and tolerability of TC-5214 at higher single doses than previously administered to humans. Also in Part B to evaluate the effect of two different doses of TC-5214, one at the expected therapeutic level and one above this level, on the electrical activity of the heart.Part A: there will be 3 visits to the unit by 12 volunteers, including a residential visit lasting between 17 days/16 nights up to 30 days/29 nights. Part B: this will involve a total of approximately 52 volunteers; there will be 6 visits to the unit, including 4 residential visits each lasting between 5 days/4 nights.An optional part of this study involves the collection of a blood sample for genetic (DNA) and/or biological research. TC-5214 is being developed by AstraZeneca and this study is being carried out on their behalf by Quintiles Drug Research Unit at Guy??s Hospital.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  11/LO/0320

• Date of REC Opinion

  1 Jun 2011

• REC opinion

  Further Information Favourable Opinion