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

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

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.

Study Overview

• Status: Completed
• Conditions: HCV Infection
• Intervention / Treatment: Drug: ANA773; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Academisch Medisch Centrum (AMC)
  • Groningen, Netherlands
    • PRA Clinical Research Unit
  • Rotterdam, Netherlands
    • Erasmus MC (EMC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)	Drug: ANA773; ANA773 Tosylate Capsule; Drug: Placebo; Matching Placebo Capsule
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)	Drug: ANA773; ANA773 Tosylate Capsule; Drug: Placebo; Matching Placebo Capsule
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)	Drug: ANA773; ANA773 Tosylate Capsule; Drug: Placebo; Matching Placebo Capsule
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)	Drug: ANA773; ANA773 Tosylate Capsule; Drug: Placebo; Matching Placebo Capsule
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)	Drug: ANA773; ANA773 Tosylate Capsule; Drug: Placebo; Matching Placebo Capsule
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)	Drug: ANA773; ANA773 Tosylate Capsule; Drug: Placebo; Matching Placebo Capsule
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)	Drug: ANA773; ANA773 Tosylate Capsule; Drug: Placebo; Matching Placebo Capsule
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)	Drug: ANA773; ANA773 Tosylate Capsule; Drug: Placebo; Matching Placebo Capsule
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)	Drug: ANA773; ANA773 Tosylate Capsule; Drug: Placebo; Matching Placebo Capsule

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: September 27, 2010
• First Submitted That Met QC Criteria: September 28, 2010
• First Posted (Estimate): September 29, 2010

Study Record Updates

• Last Update Posted (Estimate): November 14, 2012
• Last Update Submitted That Met QC Criteria: November 12, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis; Infections; Hepatitis C
• Other Study ID Numbers: ANA773-601