Study of ABT-333 in Both Healthy Volunteers and Hepatitis C Virus (HCV) + Genotype 1 Infected Subjects

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics of ABT-333 in healthy volunteers and the antiviral activity in HCV infected subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Abbott; AbbVie

Criteria

Inclusion Criteria:

• Main Selection Criteria for Healthy Volunteers:

• Subject has provided written consent.

• Subject is in general good health.

• If female, subject is postmenopausal.

• If female, subject is not pregnant and is not breast-feeding.

• Main Selection Criteria for HCV+ Subjects:

• Subject is HAV-IgM, HBsAg or HIV Ab negative.

• Subject is HCV genotype 1 with HCV RNA of > 50,000 IU/mL.

• Subject is excluded if they have previously received antiviral therapy for HCV infection

• Subjects must demonstrate chronic hepatitis C infection for at least 6 months prior to study enrollment

• Subjects must have a prior liver biopsy with histology consistent with HCV induced liver damage, and with no evidence of cirrhosis or liver pathology due to any cause other than chronic HCV.

Exclusion Criteria:

See above for main selection criteria