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

NCT01211626 | Completed Phase 1 DMC

• 1 other identifier: ANA773-601
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 3

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.

Conditions

HCV Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Immunological effects in both Healthy Subjects and Chronic HCV Patients

  Up to 41 days

Study Arms (9)

Part A, Group 1 Healthy Volunteer

ACTIVE COMPARATOR

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; Drug: Placebo

Part A, Group 2 Healthy Volunteer

ACTIVE COMPARATOR

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; Drug: Placebo

Part A, Group 3 Healthy Volunteer

ACTIVE COMPARATOR

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; Drug: Placebo

Part A, Group 4 Healthy Volunteer

ACTIVE COMPARATOR

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; Drug: Placebo

Part A, Group 5 Healthy Volunteer

ACTIVE COMPARATOR

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; Drug: Placebo

Part B, Group 6 HCV Infected Patient

ACTIVE COMPARATOR

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

Drug: ANA773; Drug: Placebo

Part B, Group 7 HCV Infected Patient

ACTIVE COMPARATOR

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

Drug: ANA773; Drug: Placebo

Part B, Group 8 HCV Infected Patient

ACTIVE COMPARATOR

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

Drug: ANA773; Drug: Placebo

Part B, Group 9 HCV Infected Patient

ACTIVE COMPARATOR

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

Drug: ANA773; Drug: Placebo

Interventions

ANA773 DRUG

ANA773 Tosylate Capsule

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

Placebo DRUG

Matching Placebo Capsule

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, ages 18 to 65 years
• No clinically significant abnormalities
• No serious or severe chronic conditions
• Non-smokers

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (3)

Academisch Medisch Centrum (AMC)

Amsterdam, Netherlands

Location

PRA Clinical Research Unit

Groningen, Netherlands

Location

Erasmus MC (EMC)

Rotterdam, Netherlands

Location

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2010
• First Posted: September 29, 2010
• Study Start: June 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: November 14, 2012

Record last verified: 2012-11

Locations

NL (3)