Safety, PK and Efficacy of PPI-383 In HVs & HepC patients
Research type
Research Study
Full title
A Phase Ia and Ib Dose-ranging Study to Assess the Safety, Pharmacokinetics and Antiviral Efficacy of PPI-383 In Healthy Adults and Hepatitis C Patients
IRAS ID
128627
Contact name
Stuart Mair
Contact email
Sponsor organisation
Presidio Pharmaceuticals Inc.
Eudract number
2013-000957-35
Research summary
The study drug, PPI-383 is being developed to treat Hepatitis C, a viral infection of the liver. The results of this study will be used to determine whether PPI-383 could potentially be an effective and safe new medicine for Hepatitis C patients. If the study results are encouraging, then the result of this study could be used to help choose which formulation and dose of PPI-383 should be tested in additional clinical studies, involving larger numbers of patients and longer treatment periods which will aim to cure the Hepatitis C infection.
The overall study has been designed to look at the safety of PPI-383 (the study drug), and how well the study drug is taken up by the body in healthy male volunteers and patients who are infected with Hepatitis C.
There are two parts to the study. Part 1 will initially consist of an assessment of the starting dose in 3 different formulations of the study drug in healthy volunteers. This will be followed by healthy volunteers receiving single doses of the study drug (in one or more different formulations) at a higher strength. Following this, healthy volunteers will receive once, twice or three-times daily doses of study drug in different formulations and at ascending doses or a placebo for up to 5 days. In Part II of the study, multiple doses of the study drug will be given to patients which have Hepatitis C.
REC name
HSC REC A
REC reference
13/NI/0058
Date of REC Opinion
22 May 2013
REC opinion
Further Information Favourable Opinion