A Phase 1a/1b Study of PPI-383 in Healthy Adults and Hepatitis C Patients
- Registration Number
- NCT01928147
- Lead Sponsor
- Presidio Pharmaceuticals, Inc.
- Brief Summary
PPI-383 is an antiviral agent (an inhibitor of the hepatitis C virus NS5B polymerase) that is being developed as a potential treatment for hepatitis C virus infection. This study is being done to assess the dose-related safety and tolerance of PPI-383 when given to healthy volunteers for up to 5 days (Part I of the study) and to hepatitis C patients for up to 3 days (Part II). In addition, the study will assess how much PPI-383 is absorbed into the bloodstream. In Part II, the dose-related effect of PPI-383 on the amount of hepatitis C virus in patients' bloodstream (serum HCV RNA levels) also will be assessed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 114
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PPI-383 single dose escalation in healthy volunteers Placebo There will be up to 10 sequential single dose cohorts to assess the bioavailability of different doses and formulations; a food effect cohort will be included. PPI-383 multiple dose escalation in HCV Subjects Placebo Upon completion of the single and multiple dose healthy volunteer cohorts, there will be 3, and potentially 4, sequential cohorts of HCV patients PPI-383 multiple doses in healthy volunteers Placebo Upon completion of the single dose cohorts, an additional cohort will receive the highest well-tolerated dose from the single dose cohorts or placebo once daily for five days; up to additional cohorts may receive multiple doses of different formulations or different regimens PPI-383 single dose escalation in healthy volunteers PPI-383 There will be up to 10 sequential single dose cohorts to assess the bioavailability of different doses and formulations; a food effect cohort will be included. PPI-383 multiple doses in healthy volunteers PPI-383 Upon completion of the single dose cohorts, an additional cohort will receive the highest well-tolerated dose from the single dose cohorts or placebo once daily for five days; up to additional cohorts may receive multiple doses of different formulations or different regimens PPI-383 multiple dose escalation in HCV Subjects PPI-383 Upon completion of the single and multiple dose healthy volunteer cohorts, there will be 3, and potentially 4, sequential cohorts of HCV patients
- Primary Outcome Measures
Name Time Method Safety and tolerability, as measured by clinical adverse events and laboratory assessments Part I, up to day 12; and Part II, up to day 17
- Secondary Outcome Measures
Name Time Method PPI-383 plasma levels Part I, up to day 12; and Part II, up to day 17 serum HCV RNA levels Part II, up to day 17
Trial Locations
- Locations (1)
Investigational site
🇬🇧Nottingham, United Kingdom