KUC-7483 TQT study in Caucasian and Japanese volunteers

• Research type

  Research Study

• Full title

  A double-blind, randomised, placebo-controlled, 4-way cross-over study to evaluate the effect of a therapeutic and a supra-therapeutic single dose of KUC-7483 on the QT/QTc interval of the ECG using a single 400 mg dose of Moxifloxacin as a positive control in healthy male and female, Caucasian and Japanese volunteers, with a 14-day extension to investigate multiple supra-therapeutic doses on the QT/QTc interval of the ECG.

• IRAS ID

  48809

• Contact name

  Jorg Taubel

• Sponsor organisation

  Kissei Pharmaceutical Co., LTD.

• Eudract number

  2010-019087-37

• Research summary

  This study aims to compare the effect of a single dose of KUC-7483 (anticipated therapeutic and supra-therapeutic doses) to placebo on the changes in the ECG (electrocardiogram - electrical heart tracing) using a 400 mg dose of moxifloxacin compared to a placebo as a positive control. The study will also evaluate the safety and tolerability of KUC-7483 and assess the amount of KUC-7483 that enters the blood. This study will be split into two parts: Part 1 is a cross-over design whereby volunteers will be given each of two doses of KUC-7483, moxifloxacin and placebo in four separate periods; Part 2 will explore multiple doses of KUC-7483 and placebo. The study will take approximately 12 weeks to complete (for each volunteer). This study has been designed and sponsored by Kissei Pharmaceutical Co., LTD. and will be conducted at Richmond Pharmacology Limited (RPL). This study will involve up to 60 healthy Caucasian and Japanese males and females aged 20-45 years inclusive. Since there are possible differences in how the IMP is handled by the body in different ethnic groups, the IMP must be assessed in Japanese volunteers before it can be given to Japanese patients. KUC-7483 is a new drug being developed for the treatment of overactive bladder (OAB), a urinary bladder disorder with symptoms that include frequent urination, urgency of urination and urge incontinence. This is not a life threatening disease but limits a patient's daily activities and lowers their quality of life. KUC-7483 is not available by prescription or over the counter medication but is under research in clinical trials. It will be given to volunteers by mouth as a tablet.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/IEC07/2

• Date of REC Opinion

  6 Apr 2010

• REC opinion

  Further Information Favourable Opinion