Clinical trial NCT01211626: Study of ANA773 in Healthy Volunteers and Patients With Hepatitis C Virus (HCV) to Assess Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HCV Infection
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-09-29
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Safety and Pharmacokinetic Analysis in both Healthy Subjects and Chronic HCV Patients
timeFrame: Up to 41 Days
Secondary outcomes:
measure: Immunological effects in both Healthy Subjects and Chronic HCV Patients
timeFrame: Up to 41 days
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum (AMC)
city: Groningen
country: Netherlands
facility: PRA Clinical Research Unit
city: Rotterdam
country: Netherlands
facility: Erasmus MC (EMC)
Study officials:
References: