Study of ANA773 in Healthy Volunteers and Patients With Hepatitis C Virus (HCV) to Assess Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD)

Study Overview
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Brief Summary
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The overall study design includes two parts, Part A and Part B. Part A evaluated ANA773 following oral administration to healthy volunteers. A total of 40 evaluable healthy volunteers were enrolled in Part A of the study. Part B evaluated ANA773 following oral administration to patients with chronic HCV infection. A total of 34 evaluable patients were enrolled in Part B of this study in 2 study centers.

Detailed Description
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Study Design: Part A evaluated ANA773 following oral administration to healthy volunteers. A total of 40 evaluable healthy volunteers were enrolled in Part A of the study. Part B evaluated ANA773 following oral administration to patients with chronic HCV infection. A total of 34 evaluable patients were enrolled in Part B of this study in 2 study centers.

Official Title
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A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple Dose Study in Healthy Volunteers and Patients With Chronic Hepatitis C Viral Infection to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ANA773 Tosylate

Conditions
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HCV Infection

Intervention / Treatment
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* Drug: ANA773
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Part A Inclusion: Male or female, ages 18 to 65 years No clinically significant abnormalities No serious or severe chronic conditions Non-smokers Part A Exclusion: Female subjects who are pregnant or breast-feeding History of significant medical condition that could interfere with study medication or associated study assessments History of or current drug or alcohol abuse Part B Inclusion Criteria: Male or female, ages 18 to 65 years Diagnosed with chronic liver disease consistent with chronic hepatitis C infection for at least 6 months Screening HCV RNA ≥ 375,000 copies/mL or ≥ 75,000 IU/mL Naïve to or have relapsed from prior IFN-alpha based therapy Part B Exclusion Criteria: Female subjects who are pregnant or breast-feeding Received anti-viral therapy or immunomodulatory therapy within 90 days prior to administration of the first dose of study medication Use of an investigational drug or participation in an investigational study with a licensed drug within 30 days History of significant medical condition that could interfere with study medication or associated study assessments History of or current drug or alcohol abuse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Part A, Group 1 Healthy Volunteer<br>a single oral dose (Period 1) and multiple oral doses every other day (4 administrations) (Period 2) of 200 mg of ANA773 (n=6) or placebo (n=2) | Drug: ANA773<br>* ANA773 Tosylate Capsule<br>Drug: Placebo<br>* Matching Placebo Capsule<br>|
| Active Comparator: Part A, Group 2 Healthy Volunteer<br>a single oral dose (Period 1) and multiple oral doses every other day (4 administrations) (Period 2) of 400 mg of ANA773 (n=6) or placebo (n=2) | Drug: ANA773<br>* ANA773 Tosylate Capsule<br>Drug: Placebo<br>* Matching Placebo Capsule<br>|
| Active Comparator: Part A, Group 3 Healthy Volunteer<br>a single oral dose (Period 1) and multiple oral doses every other day (4 administrations) (Period 2) of 800 mg of ANA773 (n=6) or placebo (n=2) | Drug: ANA773<br>* ANA773 Tosylate Capsule<br>Drug: Placebo<br>* Matching Placebo Capsule<br>|
| Active Comparator: Part A, Group 4 Healthy Volunteer<br>a single oral dose (Period 1) and multiple oral doses every other day (4 administrations) (Period 2) of 1200 mg of ANA773 (n=6) or placebo (n=2) | Drug: ANA773<br>* ANA773 Tosylate Capsule<br>Drug: Placebo<br>* Matching Placebo Capsule<br>|
| Active Comparator: Part A, Group 5 Healthy Volunteer<br>a single oral dose (Period 1) and multiple oral doses every other day (4 administrations) (Period 2) of 1600 mg of ANA773 (n=6) or placebo (n=2) | Drug: ANA773<br>* ANA773 Tosylate Capsule<br>Drug: Placebo<br>* Matching Placebo Capsule<br>|
| Active Comparator: Part B, Group 6 HCV Infected Patient<br>multiple oral doses(14 administrations) every other day of 2000 mg of ANA773 (n=6) or placebo (n=2) | Drug: ANA773<br>* ANA773 Tosylate Capsule<br>Drug: Placebo<br>* Matching Placebo Capsule<br>|
| Active Comparator: Part B, Group 7 HCV Infected Patient<br>multiple oral doses(14 administrations) every other day of 1200 mg of ANA773 (n=6) or placebo (n=2) | Drug: ANA773<br>* ANA773 Tosylate Capsule<br>Drug: Placebo<br>* Matching Placebo Capsule<br>|
| Active Comparator: Part B, Group 8 HCV Infected Patient<br>multiple oral doses(14 administrations) every other day of 1600 mg of ANA773 (n=6) or placebo (n=2) | Drug: ANA773<br>* ANA773 Tosylate Capsule<br>Drug: Placebo<br>* Matching Placebo Capsule<br>|
| Active Comparator: Part B, Group 9 HCV Infected Patient<br>multiple oral doses(5 administrations) every other day of 2000 mg of ANA773 (n=8) or placebo (n=2) | Drug: ANA773<br>* ANA773 Tosylate Capsule<br>Drug: Placebo<br>* Matching Placebo Capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Pharmacokinetic Analysis in both Healthy Subjects and Chronic HCV Patients | Evaluate the Safety and Pharmacokinetic Analysis in both Healthy Subjects and Chronic HCV Patients | Up to 41 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunological effects in both Healthy Subjects and Chronic HCV Patients | Evaluate the immunological effects and antiviral activity as assessed by changes in HCV RNA levels. | Up to 41 days |