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

November 24, 2015 updated by: Presidio Pharmaceuticals, Inc.

A Phase Ia and Ib Dose-Ranging Study to Assess the Safety, Pharmacokinetics, and Antiviral Efficacy of PPI-383 in Healthy Adults and Hepatitis C Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mauritius
      • Phoenix, Mauritius
        • Investigational Site
  • United Kingdom
      • London, United Kingdom, SE5 9RS
        • Investigational Site
      • London, United Kingdom, NW3 2QG
        • Investigational Site
      • London, United Kingdom, UE1 2AD
        • Investigational Site
      • London, United Kingdom, W2 1NY
        • Investigational Site
      • Nottingham, United Kingdom
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Part I volunteers (single and multiple dose) - key inclusion criteria

  • Healthy males
  • Age 18 to 55 years
  • Body mass index (BMI)18 to 32 kg/m2

Part II patients- key inclusion criteria

  • Males, or females of non-childbearing potential
  • Age 18 to 65 years
  • Chronic hepatitis C, and absence of other known liver disease
  • Seropositive for HCV antibody (HCV Ab) or HCV RNA at least once previously
  • Seropositive for HCV Ab at screening
  • Serum HCV RNA > 5 log10 IU/mL at screening
  • HCV gt-1
  • Treatment-naïve for hepatitis C:
  • BMI 18 to 35 kg/m2
  • Otherwise in good health, without severe or clinically significant chronic or recurrent conditions requiring frequent medical intervention or continual pharmacologic management, except for anti-hypertensive use
  • No medical or psychosocial conditions that would potentially interfere with the subject's ability to comply with the study assessments or visit schedule.

Part II patients - key exclusion criteria

  • Seropositive for human immunodeficiency virus (HIV) antibody or hepatitis B virus (HBV) surface antigen (HBsAg)
  • Signs or symptoms of decompensated liver disease
  • Evidence of cirrhosis or hepatocellular carcinoma
  • Diabetes Mellitus treated with insulin or hypoglycemic agents
  • Asthma requiring hospital admission within the preceding 12 months
  • History of alcohol abuse or illicit drug use which could interfere with a patient's compliance with the protocol requirements

  • Any of the following laboratory values at screening

    • Haemoglobin (Hgb) <11 g/dL in women or 12 g/dL in men
    • White blood cell count <4,000/mm3
    • Absolute neutrophil count (ANC) < 1800 per mm3
    • Platelet count <100,000 per mm3
    • Serum creatinine > upper limit of normal (ULN) at the central study laboratory
    • Serum albumin <3.4 g/dL
    • Total bilirubin >2.0 mg/dL
  • Clinically significant abnormality in the electrocardiograms (ECGs) at screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PPI-383 single dose escalation in healthy volunteers
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.
Drug: Placebo
Drug: PPI-383
Experimental: PPI-383 multiple doses in healthy volunteers
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
Drug: Placebo
Drug: PPI-383
Experimental: PPI-383 multiple dose escalation in HCV Subjects
Upon completion of the single and multiple dose healthy volunteer cohorts, there will be 3, and potentially 4, sequential cohorts of HCV patients
Drug: Placebo
Drug: PPI-383

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability, as measured by clinical adverse events and laboratory assessments
Time Frame: Part I, up to day 12; and Part II, up to day 17
Part I, up to day 12; and Part II, up to day 17

Secondary Outcome Measures

Outcome Measure
Time Frame
serum HCV RNA levels
Time Frame: Part II, up to day 17
Part II, up to day 17
PPI-383 plasma levels
Time Frame: Part I, up to day 12; and Part II, up to day 17
Part I, up to day 12; and Part II, up to day 17

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Presidio Pharmaceuticals, Inc.

Investigators

  • Study Director: Nathaniel Brown, M.D., Presidio Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

August 19, 2013

First Submitted That Met QC Criteria

August 20, 2013

First Posted (Estimate)

August 23, 2013

Study Record Updates

Last Update Posted (Estimate)

November 26, 2015

Last Update Submitted That Met QC Criteria

November 24, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPI-383-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatitis C, Chronic

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe