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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: August 2009

Detailed Description

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.

Interventions

  • Drug: ANA773
    • ANA773 Tosylate Capsule
  • Drug: Placebo
    • Matching Placebo Capsule

Arms, Groups and Cohorts

  • Active Comparator: Part A, Group 1 Healthy Volunteer
    • 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)
  • Active Comparator: Part A, Group 2 Healthy Volunteer
    • 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)
  • Active Comparator: Part A, Group 3 Healthy Volunteer
    • 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)
  • Active Comparator: Part A, Group 4 Healthy Volunteer
    • 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)
  • Active Comparator: Part A, Group 5 Healthy Volunteer
    • 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)
  • Active Comparator: Part B, Group 6 HCV Infected Patient
    • multiple oral doses(14 administrations) every other day of 2000 mg of ANA773 (n=6) or placebo (n=2)
  • Active Comparator: Part B, Group 7 HCV Infected Patient
    • multiple oral doses(14 administrations) every other day of 1200 mg of ANA773 (n=6) or placebo (n=2)
  • Active Comparator: Part B, Group 8 HCV Infected Patient
    • multiple oral doses(14 administrations) every other day of 1600 mg of ANA773 (n=6) or placebo (n=2)
  • Active Comparator: Part B, Group 9 HCV Infected Patient
    • multiple oral doses(5 administrations) every other day of 2000 mg of ANA773 (n=8) or placebo (n=2)

Clinical Trial Outcome Measures

Primary Measures

  • Safety and Pharmacokinetic Analysis in both Healthy Subjects and Chronic HCV Patients
    • Time Frame: Up to 41 Days
    • Evaluate the Safety and Pharmacokinetic Analysis in both Healthy Subjects and Chronic HCV Patients

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Hoffmann-La Roche
  • Provider of Information About this Clinical Study
    • Sponsor

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