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

AbbVie

Status and phase: Completed; Phase 1

Conditions: HCV Infection

Treatments: Drug: Placebo; Drug: ABT-333

Study type: Interventional

Funder types: Industry

Identifiers

NCT00696904

M10-351

Details and patient eligibility

About

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.

Full 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.

Enrollment: 133 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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133 participants in 3 patient groups

1

Other group

Description:

Healthy volunteers, receiving 10-1200 mg ABT-333 or placebo, single dose

Treatment:

Drug: ABT-333

Drug: Placebo

2

Other group

Description:

HCV+ treatment-naive subjects receiving 100-300 mg ABT-333 or placebo, multi-dose, QD or BID

Treatment:

Drug: ABT-333

Drug: Placebo

3

Other group

Description:

Healthy volunteers, receiving 100 mg ABT-333, multi-dose, food effect

Treatment:

Drug: ABT-333