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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)

NCT ID: NCT01211626

Last Updated: 2012-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-08-31

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.

Conditions

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HCV Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

ANA773

Intervention Type DRUG

ANA773 Tosylate Capsule

Placebo

Intervention Type DRUG

Matching Placebo Capsule

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)

Group Type ACTIVE_COMPARATOR

ANA773

Intervention Type DRUG

ANA773 Tosylate Capsule

Placebo

Intervention Type DRUG

Matching Placebo Capsule

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)

Group Type ACTIVE_COMPARATOR

ANA773

Intervention Type DRUG

ANA773 Tosylate Capsule

Placebo

Intervention Type DRUG

Matching Placebo Capsule

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)

Group Type ACTIVE_COMPARATOR

ANA773

Intervention Type DRUG

ANA773 Tosylate Capsule

Placebo

Intervention Type DRUG

Matching Placebo Capsule

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)

Group Type ACTIVE_COMPARATOR

ANA773

Intervention Type DRUG

ANA773 Tosylate Capsule

Placebo

Intervention Type DRUG

Matching Placebo Capsule

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)

Group Type ACTIVE_COMPARATOR

ANA773

Intervention Type DRUG

ANA773 Tosylate Capsule

Placebo

Intervention Type DRUG

Matching Placebo Capsule

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)

Group Type ACTIVE_COMPARATOR

ANA773

Intervention Type DRUG

ANA773 Tosylate Capsule

Placebo

Intervention Type DRUG

Matching Placebo Capsule

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)

Group Type ACTIVE_COMPARATOR

ANA773

Intervention Type DRUG

ANA773 Tosylate Capsule

Placebo

Intervention Type DRUG

Matching Placebo Capsule

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)

Group Type ACTIVE_COMPARATOR

ANA773

Intervention Type DRUG

ANA773 Tosylate Capsule

Placebo

Intervention Type DRUG

Matching Placebo Capsule

Interventions

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ANA773

ANA773 Tosylate Capsule

Intervention Type DRUG

Placebo

Matching Placebo Capsule

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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


* 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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Academisch Medisch Centrum (AMC)

Amsterdam, , Netherlands

Site Status

PRA Clinical Research Unit

Groningen, , Netherlands

Site Status

Erasmus MC (EMC)

Rotterdam, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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ANA773-601

Identifier Type: -

Identifier Source: org_study_id