Investigation of 2 Dose Titration Regimens of KRP203

• Research type

  Research Study

• Full title

  A double blind, placebo controlled, parallel group study to investigate the effect of two different dose-titration regimens on the initial negative chronotropic effect of KRP203 in healthy subjects.

• IRAS ID

  58438

• Contact name

  Salvatore Febbraro

• Sponsor organisation

  Novartis Pharma AG

• Eudract number

  2010-018943-32

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The drug being tested in this study is called KRP203 and it??s being developed for the treatment of conditions such as Multiple Sclerosis (MS) and Ulcerated Colitis (UC); a form of inflammatory bowel disease (IBD). This is the third study in which KRP203 has been given to humans. The purpose of this study is to examine the effects of KRP203 on the body, after it has been administered according to different treatment regimens for a period of 21 days. This study will be conducted in a total of 56 subjects. Each subject will be assigned to 1 of 4 treatment groups: titration group 1, titration group 2, fixed-dose group or placebo group. This is a ??blind? study therefore neither the subject nor clinical staff will know the treatment allocation. Safety assessments will be performed on each subject throughout the study. These will include physical examinations and measurements of blood pressure, pulse, temperature, 12-lead ECG and lung function. Monitoring of any new signs or symptoms will be continuous. Blood and urine samples will be collected for laboratory safety tests (including HIV, Hepatitis B and C), to confirm the subject has abstained from alcohol, tobacco and illicit drugs, and to confirm negative pregnancy status in all female volunteers. Blood samples will be taken in order for levels of KRP203 and its breakdown product to be measured. KRP203 has previously demonstrated an effect on white blood cell count in the blood, therefore additional blood samples will be taken to assess this effect. The safety and welfare of the volunteers have been fully considered and will continue to be paramount during the course of the research study.

• REC name

  Wales REC 2

• REC reference

  10/WSE02/43

• Date of REC Opinion

  22 Jul 2010

• REC opinion

  Further Information Favourable Opinion