Overview

A Randomized Study to Evaluate the Safety, Tolerability and Antiviral Activity of ABT-450, ABT-333 and ABT-072

Status:
Completed
Trial end date:
2012-01-01
Target enrollment:
0
Participant gender:
All
Summary
This study assessed the safety, tolerability, pharmacokinetics, and antiviral activity of multiple oral doses of ABT-450/ritonavir (r), ABT-333 (also known as dasabuvir), or ABT-072 in hepatitis C virus (HCV), genotype 1-infected, treatment-naïve adults.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Treatments:
Antiviral Agents
Peginterferon alfa-2a
Ribavirin
Ritonavir
Criteria
Inclusion Criteria:

- Chronic hepatitis C virus (HCV), genotype 1 infection (HCV ribonucleic acid level
greater than or equal to 100,000 IU/mL) at screening

- Liver biopsy within 3 years with histology consistent with HCV-induced liver damage,
with no evidence of cirrhosis or liver pathology due to any cause other than chronic
HCV

- Treatment naïve male or female between the ages of 18 and 65

- Females must be post-menopausal for more than 2 years or surgically sterile

- Negative screen for drugs and alcohol

- Negative hepatitis B surface antigen (HBsAg) and anti-human immunodeficiency virus
antibodies (anti-HIV Ab)

- No use of cytochrome P450 3A (CYP3A) and cytochrome P450 2C8 (CYP2C8) enzyme inducers
or inhibitors within 1 month of dosing

- Be in a condition of general good health, as perceived by the investigator, other than
HCV infection

Exclusion Criteria:

- Significant sensitivity to any drug

- Use of herbal supplements within 2 weeks prior to study drug dosing

- History of major depression within 2 years

- Prior treatment with any investigational or commercially available anti-HCV agents

- Abnormal laboratory tests