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

Hepatitis C, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01928147
• Other study ID #: PPI-383-101
• Status: Completed
• Phase: Phase 1
• First received: August 19, 2013
• Last updated: November 24, 2015
• Start date: August 2013
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Presidio Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyFrance: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of PersonnesMauritius: Ministry of Health and Quality of Life
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: November 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Drug:
• PPI-383

• Placebo

Locations

Country	Name	City	State
Mauritius	Investigational site	Phoenix
United Kingdom	Investigational site	London
United Kingdom	Investigational site	London
United Kingdom	Investigational site	London
United Kingdom	Investigational site	London
United Kingdom	Investigational site	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Presidio Pharmaceuticals, Inc.

Countries where clinical trial is conducted

Mauritius,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability, as measured by clinical adverse events and laboratory assessments		Part I, up to day 12; and Part II, up to day 17	Yes
Secondary	PPI-383 plasma levels		Part I, up to day 12; and Part II, up to day 17	No
Secondary	serum HCV RNA levels		Part II, up to day 17	No