Safety, PK and food effect of Debio 025 in Japanese and Caucasians

• Research type

  Research Study

• Full title

  A 2-part study to determine a) the safety and pharmacokinetics of single and multiple escalating doses of Debio 025 in healthy Japanese volunteers in comparison with healthy Caucasian volunteers and b) to assess the food effect of a single dose of Debio 025 administered in healthy Japanese volunteers

• IRAS ID

  57968

• Contact name

  Ulrike Lorch

• Sponsor organisation

  Debiopharm S.A.

• Eudract number

  2010-020784-20

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This study is divided into two parts. Part 1 aims to determine the single and repeated escalating dose safety and pharmacokinetic profile of Debio 025 at 400mg, 600mg and 800mg in healthy Caucasian and Japanese volunteers. Part 2 assesses the food effect of single dose of Debio 025 at 600mg in healthy Japanese volunteers under three different breakfast conditions. The study drug has been tested in eight studies on healthy volunteers and three studies on patients.This study will involve 72 healthy male and female, Caucasian and Japanese volunteers aged 20-60 years inclusive. Part 1 will involve 60 healthy volunteers of both sexes and ethnic origin, and Part 2 will involve 12 healthy Japanesevolunteers of both sexes. This study has been designed and sponsored by Debiopharm S.A. and will be conducted at Richmond Pharmacology Limited (RPL) only.Debio 025 is an investigational medicinal product (IMP) being developed for the treatment of hepatitis C. Symptoms for acute hepatitis C include decreased appetite, tiredness, abdominal pain, jaundice, itching anflulike symptoms. Chronic hepatitis C is associated with serious complications which lead to liver disease. Hepatitis C is caused by the hepatitis C virus (HCV) against which Debio 025 has been shown to have anti-HCV properties.Debio 025 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 soft capsule of Debio 025 200mg.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  10/IEC04/16

• Date of REC Opinion

  15 Jul 2010

• REC opinion

  Further Information Favourable Opinion