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

Roche

Status and phase: Completed; Phase 1

Conditions: HCV Infection

Treatments: Drug: ANA773; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01211626

ANA773-601

Details and patient eligibility

About

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 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.

Enrollment: 75 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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75 participants in 9 patient groups

Part A, Group 1 Healthy Volunteer

Active Comparator group

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)

Treatment:

Drug: Placebo

Drug: ANA773

Part A, Group 2 Healthy Volunteer

Active Comparator group

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)

Treatment:

Drug: Placebo

Drug: ANA773

Part A, Group 3 Healthy Volunteer

Active Comparator group

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)

Treatment:

Drug: Placebo

Drug: ANA773

Part A, Group 4 Healthy Volunteer

Active Comparator group

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)

Treatment:

Drug: Placebo

Drug: ANA773

Part A, Group 5 Healthy Volunteer

Active Comparator group

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)

Treatment:

Drug: Placebo

Drug: ANA773

Part B, Group 6 HCV Infected Patient

Active Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: ANA773

Part B, Group 7 HCV Infected Patient

Active Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: ANA773

Part B, Group 8 HCV Infected Patient

Active Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: ANA773

Part B, Group 9 HCV Infected Patient

Active Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: ANA773