Overview

A Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-072 and Ribavirin (RBV)

Status:
Completed
Trial end date:
2012-04-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-072 and ribavirin (RBV) in treatment-naïve participants with genotype 1 chronic hepatitis C virus (HCV) infection.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Treatments:
Antiviral Agents
Ribavirin
Ritonavir
Criteria
Inclusion Criteria:

- Chronic hepatitis C, genotype 1 infection with interleukin 28B (IL28B) rs12979860
genotype C/C.

- Liver biopsy within 3 years with histology consistent with hepatitis C virus (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 postmenopausal for at least 2 years or surgically sterile.

- Be in a condition of general good health, as perceived by the investigator, other than
hepatitis C virus infection.

- Body mass index 18 to < 35 kg/m^2 .

Exclusion Criteria:

- Significant sensitivity to any drug.

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

- Positive screen for certain drugs or alcohol.

- Positive hepatitis B surface antigen or anti-human immunodeficiency virus (HIV)
antibody.

- Use of strong cytochrome P450 3A (CYP3A), cytochrome P450 2C8 (CYP2C8), and organic
anion transporting polypeptide 1B1 (OATP1B1) enzyme inducers or inhibitors within 1
month of dosing.

- Prior treatment with any investigational or commercially available anti-hepatitis C
virus agents.

- Abnormal laboratory tests.

- Cirrhosis or extensive bridging fibrosis.

- History of cardiac disease.