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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01211626
First received: September 27, 2010
Last updated: November 12, 2012
Last verified: November 2012

September 27, 2010
November 12, 2012
June 2008
August 2009   (final data collection date for primary outcome measure)
Safety and Pharmacokinetic Analysis in both Healthy Subjects and Chronic HCV Patients [ Time Frame: Up to 41 Days ] [ Designated as safety issue: Yes ]
Evaluate the Safety and Pharmacokinetic Analysis in both Healthy Subjects and Chronic HCV Patients
Same as current
Complete list of historical versions of study NCT01211626 on ClinicalTrials.gov Archive Site
Immunological effects in both Healthy Subjects and Chronic HCV Patients [ Time Frame: Up to 41 days ] [ Designated as safety issue: No ]
Evaluate the immunological effects and antiviral activity as assessed by changes in HCV RNA levels.
Same as current
Not Provided
Not Provided
 
Study of ANA773 in Healthy Volunteers and Patients With Hepatitis C Virus (HCV) to Assess Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD)
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

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
HCV Infection
  • Drug: ANA773
    ANA773 Tosylate Capsule
  • Drug: Placebo
    Matching Placebo Capsule
  • Active Comparator: 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)
    Interventions:
    • Drug: ANA773
    • Drug: Placebo
  • Active Comparator: 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)
    Interventions:
    • Drug: ANA773
    • Drug: Placebo
  • Active Comparator: 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)
    Interventions:
    • Drug: ANA773
    • Drug: Placebo
  • Active Comparator: 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)
    Interventions:
    • Drug: ANA773
    • Drug: Placebo
  • Active Comparator: 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)
    Interventions:
    • Drug: ANA773
    • Drug: Placebo
  • Active Comparator: 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)
    Interventions:
    • Drug: ANA773
    • Drug: Placebo
  • Active Comparator: 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)
    Interventions:
    • Drug: ANA773
    • Drug: Placebo
  • Active Comparator: 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)
    Interventions:
    • Drug: ANA773
    • Drug: Placebo
  • Active Comparator: 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)
    Interventions:
    • Drug: ANA773
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
August 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01211626
ANA773-601
Yes
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Not Provided
Hoffmann-La Roche
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP