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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00696904

Enrollment

133

Registered

2008-06-13

Start date

2008-06-30

Completion date

Unknown

Last updated

2017-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HCV Infection

Brief 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.

Detailed description

Phase 1, double-blind, randomized, placebo-controlled clinical trial in healthy and HCV genotype 1 infected adults to evaluate safety, tolerability, antiviral activity and pharmacokinetics of ABT-333.

Interventions

DRUGABT-333

Capsule, see arms for intervention description

DRUGPlacebo

Capsule, see arms for intervention description

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Analysis of pharmacokinetic variables and mean change in HCV RNA level from baseline.	approximately 1 week or less
Analysis of safety measures, including but not limited to tabulation of adverse events, physical exam, clinical lab results (include chemistry, hematology and urine) and vital signs.	approximately 1 week

Secondary

Measure	Time frame
Analysis of variance of pharmacokinetic variables for subjects fasting or nonfasting.	approximately 1 week

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026