A study to assess the safety, antiviral efficacy and PK of PPI-461

• Research type

  Research Study

• Full title

  A Phase 1b Study to Assess the Safety, Antiviral Efficacy and Pharmacokinetics of PPI-461, Alone and in Combination with Peginterferon-alfa/Ribavirin, in Patients with HCV Genotype-1 Infection

• IRAS ID

  60182

• Contact name

  Geoffrey Dusheiko

• Sponsor organisation

  Presidio Pharmaceuticals, Inc

• Eudract number

  2010-021510-36

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This study will examine the safety and blood levels of PPI-461 after its administration to adult hepatitis C patients, and the inhibitory effects of PPI-461 on HCV viral levels in patients’ blood. This study will be conducted in two parts. Part I will assess PPI-461 dosing in 3 sequential groups, each consisting of 8 patients (6 treated with active PPI-461 capsules, 2 with matching placebo capsules). Patients will receive once daily oral doses of PPI-461 for 3 days. Different doses will be given to each group, starting with the lowest dose (50 mg) in the first group and proceeding to higher doses (100 mg/day, then 200 mg/day) in subsequent groups only if study treatment in the previous group(s) has been well-tolerated. A fourth dose group may be enrolled in Part I, depending on the observations with the first 3 groups; the PPI-461 dose for this group could be higher or lower (maximal 400 mg/day).Part II will be conducted as 2 patient groups, each consisting of 18 patients (12 active, 6 placebo). These two groups will receive 14 days of treatment with daily oral doses of PPI-461 in combination with standard therapy, consisting of weekly injections of peg-interferon and twice-daily oral doses of ribavirin. PPI-461 doses will be different in the two groups, and will be equal to or lower than the highest well-tolerated dose as determined in Part I. To facilitate non-biased observations, this is a ‘blinded’ study; neither the patients nor the clinical staff will know patients’ randomized treatment assignments (active PPI-461 capsules or placebo), in Part I or Part II. After the last dose of study drug, all patients will be evaluated for 2 additional weeks, for follow-up assessments of safety, drug washout, and viral levels. Patients completing the study may be elected for follow-on treatment with peg-interferon and ribavirin, at investigator discretion.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  10/H0703/70

• Date of REC Opinion

  14 Oct 2010

• REC opinion

  Further Information Favourable Opinion