Nitazoxanide TQT study in healthy male and female 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 Nitazoxanide on the QT/QTc interval of the ECG using a single 400mg dose of Moxifloxacin as a positive control in healthy male and female volunteers.

• IRAS ID

  59093

• Contact name

  j taubel

• Sponsor organisation

  Romark Laboratories, L.C.

• Eudract number

  2010-022801-16

• Research summary

  Nitazoxanide is marketed in the United States for treating diarrhoea by parasitic infection and in Latin America as a broad-spectrum anti-parasitic agent. Currently, it is being developed for the treatment of chronic hepatitis C.This study aims to compare the effect of a single dose of Nitazoxanide (anticipated therapeutic and supra-therapeutic doses) to placebo on the changes in the ECG (electrocardiogram - electrical heart tracing) using a 400mg dose of Moxifloxacin compared to a placebo as a positive control. The study will also evaluate the safety and tolerability of Nitazoxanide and assess the amount of Nitazoxanide that enters the blood. This study is a cross-over design whereby volunteers will be given each of two doses of Nitazoxanide, Moxifloxacin and placebo in four separate periods. The study will take approximately 13 weeks to complete (for each volunteer). This study has been designed and sponsored by Romark Laboratories, L.C. (Romark) and will be conducted at Richmond Pharmacology Limited (RPL).This study will involve up to 56 healthy males and females aged 20-45 years inclusive. Nitazoxanide will be given to volunteers by mouth in tablet form.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/IEC07/21

• Date of REC Opinion

  6 Oct 2010

• REC opinion

  Further Information Favourable Opinion