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

Primary Purpose

HCV Infection

Status

Completed

Phase

Phase 1

Locations

Netherlands

Study Type

Interventional

Intervention

ANA773

Placebo

About this trial

This is an interventional treatment trial for HCV Infection

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Academisch Medisch Centrum (AMC)
PRA Clinical Research Unit
Erasmus MC (EMC)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Active Comparator

Arm Label

Part A, Group 1 Healthy Volunteer

Part A, Group 2 Healthy Volunteer

Part A, Group 3 Healthy Volunteer

Part A, Group 4 Healthy Volunteer

Part A, Group 5 Healthy Volunteer

Part B, Group 6 HCV Infected Patient

Part B, Group 7 HCV Infected Patient

Part B, Group 8 HCV Infected Patient

Part B, Group 9 HCV Infected Patient

Arm Description

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)

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)

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)

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)

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)

multiple oral doses(14 administrations) every other day of 2000 mg of ANA773 (n=6) or placebo (n=2)

multiple oral doses(14 administrations) every other day of 1200 mg of ANA773 (n=6) or placebo (n=2)

multiple oral doses(14 administrations) every other day of 1600 mg of ANA773 (n=6) or placebo (n=2)

multiple oral doses(5 administrations) every other day of 2000 mg of ANA773 (n=8) or placebo (n=2)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01211626

First Posted

September 27, 2010

Last Updated

November 12, 2012

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT01211626

Brief Title

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

Official Title

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

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Completed

Study Start Date

June 2008 (undefined)

Primary Completion Date

August 2009 (Actual)

Study Completion Date

August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HCV Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

75 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part A, Group 1 Healthy Volunteer

Arm Type

Active Comparator

Arm Description

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)

Arm Title

Part A, Group 2 Healthy Volunteer

Arm Type

Active Comparator

Arm Description

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)

Arm Title

Part A, Group 3 Healthy Volunteer

Arm Type

Active Comparator

Arm Description

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)

Arm Title

Part A, Group 4 Healthy Volunteer

Arm Type

Active Comparator

Arm Description

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)

Arm Title

Part A, Group 5 Healthy Volunteer

Arm Type

Active Comparator

Arm Description

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)

Arm Title

Part B, Group 6 HCV Infected Patient

Arm Type

Active Comparator

Arm Description

multiple oral doses(14 administrations) every other day of 2000 mg of ANA773 (n=6) or placebo (n=2)

Arm Title

Part B, Group 7 HCV Infected Patient

Arm Type

Active Comparator

Arm Description

multiple oral doses(14 administrations) every other day of 1200 mg of ANA773 (n=6) or placebo (n=2)

Arm Title

Part B, Group 8 HCV Infected Patient

Arm Type

Active Comparator

Arm Description

multiple oral doses(14 administrations) every other day of 1600 mg of ANA773 (n=6) or placebo (n=2)

Arm Title

Part B, Group 9 HCV Infected Patient

Arm Type

Active Comparator

Arm Description

multiple oral doses(5 administrations) every other day of 2000 mg of ANA773 (n=8) or placebo (n=2)

Intervention Type

Drug

Intervention Name(s)

ANA773

Intervention Description

ANA773 Tosylate Capsule

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching Placebo Capsule

Primary Outcome Measure Information:

Title

Safety and Pharmacokinetic Analysis in both Healthy Subjects and Chronic HCV Patients

Description

Evaluate the Safety and Pharmacokinetic Analysis in both Healthy Subjects and Chronic HCV Patients

Time Frame

Up to 41 Days

Secondary Outcome Measure Information:

Title

Immunological effects in both Healthy Subjects and Chronic HCV Patients

Description

Evaluate the immunological effects and antiviral activity as assessed by changes in HCV RNA levels.

Time Frame

Up to 41 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Academisch Medisch Centrum (AMC)

City

Amsterdam

Country

Netherlands

Facility Name

PRA Clinical Research Unit

City

Groningen

Country

Netherlands

Facility Name

Erasmus MC (EMC)

City

Rotterdam

Country

Netherlands

12. IPD Sharing Statement

Learn more about this trial

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

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