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Completed

NCT Number: NCT00696904

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

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.

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Key information

Conditions

HCV Infection Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABT-333

Drug

Capsule, see arms for intervention description

Placebo

Drug

Capsule, see arms for intervention description

Primary outcomes

  1. Analysis of pharmacokinetic variables and mean change in HCV RNA level from baseline.

    Time frame: approximately 1 week or less

  2. 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.

    Time frame: approximately 1 week

Secondary outcomes

  1. Analysis of variance of pharmacokinetic variables for subjects fasting or nonfasting.

    Time frame: approximately 1 week

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Important dates

Study start
2008
Primary completion
2009
First posted
Jun 13, 2008
Registry last updated
Nov 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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