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

Phase 1

Completed

• Conditions: HCV Infection
• Interventions: Drug: ANA773; Drug: Placebo

• Registration Number: NCT01211626
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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

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 Timeline

• Study Start: 2008-06
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Study First Submitted: 2010-09-27
• Study First Submitted QC: 2010-09-28
• Study First Posted: 2010-09-29
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-12
• Last Update Posted: 2012-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Safety and Pharmacokinetic Analysis in both Healthy Subjects and Chronic HCV Patients	Up to 41 Days	Evaluate the Safety and Pharmacokinetic Analysis in both Healthy Subjects and Chronic HCV Patients

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Erasmus MC (EMC); 🇳🇱 Rotterdam, Netherlands

Academisch Medisch Centrum (AMC); 🇳🇱 Amsterdam, Netherlands

PRA Clinical Research Unit; 🇳🇱 Groningen, Netherlands