Status:
COMPLETED
A Phase 1 Study of PPI-668 in Healthy Volunteers and Patients With Hepatitis C Virus (HCV) Genotype 1
Lead Sponsor:
Presidio Pharmaceuticals, Inc.
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
PPI-668 is an antiviral agent (a hepatitis C NS5A inhibitor) that is being developed as a potential treatment for hepatitis C virus infection. This study is being done to assess the safety and toleran...
Eligibility Criteria
Inclusion
- In order to participate in the study, volunteers for Part I and patients for Part II must meet all of the following key entry criteria, as well as other entry criteria specified in the full protocol:
- Key Inclusion Criteria
- Male or female, between 18 and 65 years of age. Female patients must be surgically sterile or two years post-menopausal.
- Body Mass Index (BMI) 18 - 35 kg/m2
- In good health, in the judgment of the Principal Investigator
- Able and willing to comply with all protocol requirements and to sign an informed consent.
- Key Exclusion Criteria:
- Seropositive for HIV antibody, or HBV surface antigen (HBsAg) at Screen. Volunteer subjects for Part I must also be negative for HCV antibody.
- Any medical condition that may interfere with the absorption, distribution or elimination of study drug (PPI-668), or with the clinical and laboratory assessments in this study.
- Poorly controlled or unstable hypertension; or sustained systolic BP \> 150 or diastolic BP \> 95 at Screen.
- History of Diabetes Mellitus treated with insulin or hypoglycemic agents
- History of alcohol abuse or illicit drug use which, in the investigator's judgment, could interfere with a patient's compliance, with the protocol requirements or with the safety or efficacy assessments of the study
- History of malignancy unless the malignancy has been in complete remission and without additional medical or surgical interventions during the preceding three years
- No clinically significant laboratory abnormalities at Screen for healthy volunteers in Part I. For Screen laboratory parameters for HCV patients in Part II, refer to the 'Additional Criteria for HCV Patients' below.
- Additional Key Entry Criteria for HCV patients (Part II):
- Clinical diagnosis of chronic hepatitis C, documented by:
- Clinical findings compatible with chronic hepatitis C, and absence of other known liver disease
- Seropositive for HCV antibody or HCV RNA at least once previously, and at Screen
- Serum HCV RNA \> 5 log10 IU/mL at Screen, by the PCR assay at the central study laboratory
- HCV genotype-1 (1a or 1b, or non-subtypable genotype-1), or HCV genotype-2a or genotype-3a
- ALT must be \<5 x ULN at screen
- No previous treatment with interferon, pegIFN, or ribavirin for genotype-1 patients
- No history of signs or symptoms of decompensated liver disease
- Any of the following laboratory values at Screening will be exclusionary for study participation:
- 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 \>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 Screen
Exclusion
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT01448200
Start Date
October 1 2011
End Date
November 1 2012
Last Update
November 16 2012
Active Locations (7)
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1
Investigational site
Costa Mesa, California, United States
2
Investigational site
Sacramento, California, United States
3
Investigational site
San Francisco, California, United States
4
Investigational Site
San Antonio, Texas, United States