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

Primary Purpose

Hepatitis C, Chronic

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
PPI-383
Placebo
Sponsored by
Presidio Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic focused on measuring NS5B polymerase inhibitor, Phase 1, Genotype 1

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Investigational site
  • Investigational site
  • Investigational site
  • Investigational site
  • Investigational site
  • Investigational site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

PPI-383 single dose escalation in healthy volunteers

PPI-383 multiple doses in healthy volunteers

PPI-383 multiple dose escalation in HCV Subjects

Arm Description

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.

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

Upon completion of the single and multiple dose healthy volunteer cohorts, there will be 3, and potentially 4, sequential cohorts of HCV patients

Outcomes

Primary Outcome Measures

Safety and tolerability, as measured by clinical adverse events and laboratory assessments

Secondary Outcome Measures

PPI-383 plasma levels
serum HCV RNA levels

Full Information

First Posted
August 19, 2013
Last Updated
November 24, 2015
Sponsor
Presidio Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01928147
Brief Title
A Phase 1a/1b Study of PPI-383 in Healthy Adults and Hepatitis C Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Presidio Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic
Keywords
NS5B polymerase inhibitor, Phase 1, Genotype 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PPI-383 single dose escalation in healthy volunteers
Arm Type
Experimental
Arm Description
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.
Arm Title
PPI-383 multiple doses in healthy volunteers
Arm Type
Experimental
Arm Description
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
Arm Title
PPI-383 multiple dose escalation in HCV Subjects
Arm Type
Experimental
Arm Description
Upon completion of the single and multiple dose healthy volunteer cohorts, there will be 3, and potentially 4, sequential cohorts of HCV patients
Intervention Type
Drug
Intervention Name(s)
PPI-383
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
PPI-383 plasma levels
Time Frame
Part I, up to day 12; and Part II, up to day 17
Title
serum HCV RNA levels
Time Frame
Part II, up to day 17

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathaniel Brown, M.D.
Organizational Affiliation
Presidio Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Investigational site
City
Phoenix
Country
Mauritius
Facility Name
Investigational site
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Investigational site
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Investigational site
City
London
ZIP/Postal Code
UE1 2AD
Country
United Kingdom
Facility Name
Investigational site
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Facility Name
Investigational site
City
Nottingham
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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