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

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Presidio Pharmaceuticals, Inc.

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