A study to investigate the safety and blood levels of PPI-461

• Research type

  Research Study

• Full title

  A Phase I Study to Assess the Pharmacokinetics and Safety of Single and Multiple Doses of PPI-461 in Healthy Volunteers

• IRAS ID

  49703

• Contact name

  Salvatore Febbraro

• Sponsor organisation

  Presidio Pharmaceuticals, Inc

• Eudract number

  2010-019143-19

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The drug being tested in this study is called PPI-461 and it??s being developed for the treatment of chronic hepatitis C (CHC). CHC is a liver disease associated with the hepatitis C virus (HCV) and can result in liver failure and cancer of the liver cells. PPI-461 is an antiviral agent which is being developed to provide better treatment for CHC, than what is currently available. This is the first time that PPI-461 has been given to humans. The purpose of this study is to examine the safety and levels of PPI-461 in the body after its administration to healthy volunteers. This study will be conducted as 5 groups (A-E), each consisting of 8 volunteers. Groups A-D will receive a single dose of PPI-461 after at least 10 hours fasting (different doses will be given to each group). In addition, Group B will examine whether food affects how the body responds to PPI-461. Volunteers in Group B will attend a second treatment visit, during which a high-fat meal will be provided prior to PPI-461 dosing. Group E will receive PPI-461 as a multiple dose (i.e. every day for 5 days). This is a ??blinded? study therefore neither the subject nor clinical staff will know the treatment allocation. The dose of PPI-461 is planned to ascend from Groups A-D as follows: 20, 50, 100, 200 mg. The dose administered to Group E will be equivalent to the maximum dose tolerated by the previous groups. Volunteers will endure safety assessments throughout the study. These include vital signs, ECG, blood and urine samples for safety tests, physical exams and continuous monitoring of any new signs or symptoms. Blood and Urine samples will be taken for the measurement of drug levels.

• REC name

  Wales REC 1

• REC reference

  10/WSE04/16

• Date of REC Opinion

  21 Apr 2010

• REC opinion

  Further Information Favourable Opinion