A Phase 1b Study to Assess the Safety, Antiviral Efficacy and Pharmacokinetics of PPI-461 in Patients With HCV Genotype-1 Infection
Overview
- Phase
- Phase 1
- Intervention
- PPI-461
- Conditions
- Chronic Genotype 1 Hepatitis C Virus Infection
- Sponsor
- Presidio Pharmaceuticals, Inc.
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- Safety and tolerability, as measured by clinical adverse events and laboratory assessments
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Cohort A
PPI-461 50 mg or placebo
Intervention: PPI-461
Cohort A
PPI-461 50 mg or placebo
Intervention: Placebo
Cohort B
PPI-461 100 mg or placebo
Intervention: PPI-461
Cohort B
PPI-461 100 mg or placebo
Intervention: Placebo
Cohort C
PPI-461 200 mg or placebo
Intervention: PPI-461
Cohort C
PPI-461 200 mg or placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Safety and tolerability, as measured by clinical adverse events and laboratory assessments
Time Frame: up to Study Day 16 (14 days after the last PPI-461 dose)
Antiviral effects of PPI-461, as measured by HCV RNA levels
Time Frame: Up to Study Day 16 (14 days after the last PPI-461 dose)
PPI-461 pharmacokinetics as measured by plasma PPI-461 concentrations
Time Frame: Up to Study Day 10 (8 days after the last PPI-461 dose)