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

History of Changes

Tracking Information
First Received Date ^ICMJE	September 27, 2010
Last Updated Date	November 12, 2012
Start Date ^ICMJE	June 2008
Primary Completion Date	August 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 28, 2010)	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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01211626 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 28, 2010)	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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study of ANA773 in Healthy Volunteers and Patients With Hepatitis C Virus (HCV) to Assess Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD)
Official Title ^ICMJE	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
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	HCV Infection
Intervention ^ICMJE	Drug: ANA773 ANA773 Tosylate Capsule Drug: Placebo Matching Placebo Capsule
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	75
Completion Date	August 2009
Primary Completion Date	August 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Netherlands

Administrative Information
NCT Number ^ICMJE	NCT01211626
Other Study ID Numbers ^ICMJE	ANA773-601
Has Data Monitoring Committee	Yes
Responsible Party	Hoffmann-La Roche
Study Sponsor ^ICMJE	Hoffmann-La Roche
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Hoffmann-La Roche
Verification Date	November 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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