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: PPI-461; 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

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-11-22
• Study First Submitted QC: 2010-11-22
• Study First Posted: 2010-11-24
• Primary Completion: 2011-05
• Study Completion: 2011-06
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-01
• Last Update Posted: 2012-02-03

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
PPI-461 pharmacokinetics as measured by plasma PPI-461 concentrations	Up to Study Day 10 (8 days after the last PPI-461 dose)
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)

Trial Locations

Locations (2)

Local institution; 🇬🇧 London, United Kingdom

Local Institution; 🇺🇸 Sacramento, California, United States