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

• Register: ClinicalTrials.gov
• Last refreshed on: 7 December 2015
• Main ID: NCT01928147
• Date of registration: 19/08/2013
• Prospective Registration: No
• Primary sponsor: Presidio Pharmaceuticals, Inc.
• Public title: A Phase 1a/1b Study of PPI-383 in Healthy Adults and Hepatitis C Patients
• Scientific 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
• Date of first enrolment: August 2013
• Target sample size: 114
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01928147
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Mauritius, United Kingdom

Contacts

• Name: Nathaniel Brown, M.D.
• Affiliation: Presidio Pharmaceuticals

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Hepatitis C, Chronic

Intervention(s)

Drug: PPI-383

Drug: Placebo

Primary Outcome(s)

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(s)

PPI-383 plasma levels [Time Frame: Part I, up to day 12; and Part II, up to day 17]

serum HCV RNA levels [Time Frame: Part II, up to day 17]

Secondary ID(s)

PPI-383-101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors