MedTrace Logo

A Phase 1a/1b Study of PPI-383 in Healthy Adults and Hepatitis C Patients

NCT01928147 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2015-11-26

No results posted yet for this study

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.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

PPI-383

DRUG

Placebo

Sponsors & Collaborators

  • Presidio Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Nathaniel Brown, M.D. · Presidio Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2015-07-31
Completion
2015-11-30

Countries

  • Mauritius
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01928147 on ClinicalTrials.gov