A Phase 1b Study of PPI-461 in Patients With HCV Genotype 1

Presidio Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Chronic Genotype 1 Hepatitis C Virus Infection

Treatments: Drug: PPI-461; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01247194

2010-021510-36 (EudraCT Number)

PPI-461-102

Details and patient eligibility

About

The purpose of the study is to assess the safety, tolerability, antiviral effects, and pharmacokinetics of PPI-461 in patients with chronic hepatitis C virus genotype 1 infection.

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Eligibility Criteria:

• Male or female, between 18 and 65 years of age (female patients must be surgically sterile or 2 years post-menopausal and are required to take a pregnancy test)
• Body Mass Index (BMI) 18 - 32 kg/m2
• Chronically infected with hepatitis C genotype-1 virus
• Serum HCV RNA > 5 log10 IU/mL
• No previous treatment with interferon, peginterferon, ribavirin or any investigational HCV antiviral agents
• No history of signs or symptoms of decompensated liver disease
• No known history of cirrhosis
• No co-infection with HBV, HIV-1, HIV-2
• No history of any medical condition that may interfere with absorption, distribution or elimination of study drug or with the clinical and laboratory assessments in this study
• No history of alcohol abuse, or illicit drug use within 2 years prior to Screen, or enrollment in a methadone maintenance program (unless he/she has been enrolled in the methadone program for at least 3 months with good compliance, stable psychosocial circumstances, and no known current risks for recidivism)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

24 participants in 3 patient groups

Cohort A

Active Comparator group

Description:

PPI-461 50 mg or placebo

Treatment:

Drug: Placebo

Drug: PPI-461

Cohort B

Active Comparator group

Description:

PPI-461 100 mg or placebo

Treatment:

Drug: Placebo

Drug: PPI-461

Cohort C

Active Comparator group

Description:

PPI-461 200 mg or placebo

Treatment:

Drug: Placebo

Drug: PPI-461