A Phase 1b Study of PPI-461 in Patients With HCV Genotype 1
Phase 1
Completed
- Conditions
- Chronic Genotype 1 Hepatitis C Virus Infection
- Interventions
- Drug: Placebo
- Registration Number
- NCT01247194
- Lead Sponsor
- Presidio Pharmaceuticals, Inc.
- Brief Summary
The purpose of the study is to assess the safety, tolerability, antiviral effects, and pharmacokinetics of PPI-461 in patients with chronic hepatitis C virus genotype 1 infection.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort A Placebo PPI-461 50 mg or placebo Cohort B PPI-461 PPI-461 100 mg or placebo Cohort B Placebo PPI-461 100 mg or placebo Cohort C PPI-461 PPI-461 200 mg or placebo Cohort C Placebo PPI-461 200 mg or placebo Cohort A PPI-461 PPI-461 50 mg or placebo
- Primary Outcome Measures
Name Time Method Safety and tolerability, as measured by clinical adverse events and laboratory assessments up to Study Day 16 (14 days after the last PPI-461 dose) Antiviral effects of PPI-461, as measured by HCV RNA levels Up to Study Day 16 (14 days after the last PPI-461 dose) PPI-461 pharmacokinetics as measured by plasma PPI-461 concentrations Up to Study Day 10 (8 days after the last PPI-461 dose)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Local Institution
🇺🇸Sacramento, California, United States
Local institution
🇬🇧London, United Kingdom
Local Institution🇺🇸Sacramento, California, United States