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

HCV Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01211626
• Other study ID #: ANA773-601
• Status: Completed
• Phase: Phase 1
• First received: September 27, 2010
• Last updated: November 12, 2012
• Start date: June 2008
• Est. completion date: August 2009

Study information

• Verified date: November 2012
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HCV Infection

Intervention

Drug:
• ANA773
ANA773 Tosylate Capsule
• Placebo
Matching Placebo Capsule

Locations

Country	Name	City	State
Netherlands	Academisch Medisch Centrum (AMC)	Amsterdam
Netherlands	PRA Clinical Research Unit	Groningen
Netherlands	Erasmus MC (EMC)	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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.	Up to 41 days	No