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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Presidio Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
Presidio Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01928147
First received: August 19, 2013
Last updated: August 29, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Hepatitis C, Chronic
Drug: PPI-383
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Presidio Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • PPI-383 plasma levels [ Time Frame: Part I, up to day 12; and Part II, up to day 17 ] [ Designated as safety issue: No ]
  • serum HCV RNA levels [ Time Frame: Part II, up to day 17 ] [ Designated as safety issue: No ]

Estimated Enrollment: 144
Study Start Date: August 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: PPI-383 Drug: Placebo
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: PPI-383 Drug: Placebo
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: PPI-383 Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01928147

Contacts
Contact: Presidio Pharmaceuticals 415-655-7581

Locations
United Kingdom
Investigational site Not yet recruiting
London, United Kingdom, NW3 2QG
Investigational site Not yet recruiting
London, United Kingdom, W2 1NY
Investigational site Not yet recruiting
London, United Kingdom, UE1 2AD
Investigational site Not yet recruiting
London, United Kingdom, SE5 9RS
Investigational site Recruiting
Nottingham, United Kingdom
Contact: Lorna Patrick    44 (0)115 931 5509      
Sponsors and Collaborators
Presidio Pharmaceuticals, Inc.
Investigators
Study Director: Nathaniel Brown, M.D. Presidio Pharmaceuticals
  More Information

No publications provided

Responsible Party: Presidio Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01928147     History of Changes
Other Study ID Numbers: PPI-383-101
Study First Received: August 19, 2013
Last Updated: August 29, 2014
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes

Keywords provided by Presidio Pharmaceuticals, Inc.:
NS5B polymerase inhibitor
Phase 1
Genotype 1

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Chronic
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014