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

November 17, 2017 updated by: AbbVie
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

133

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
Healthy volunteers, receiving 10-1200 mg ABT-333 or placebo, single dose
Capsule, see arms for intervention description
Capsule, see arms for intervention description
Other: 2
HCV+ treatment-naive subjects receiving 100-300 mg ABT-333 or placebo, multi-dose, QD or BID
Capsule, see arms for intervention description
Capsule, see arms for intervention description
Other: 3
Healthy volunteers, receiving 100 mg ABT-333, multi-dose, food effect
Capsule, see arms for intervention description

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Analysis of pharmacokinetic variables and mean change in HCV RNA level from baseline.
Time Frame: approximately 1 week or less
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.
Time Frame: approximately 1 week
approximately 1 week

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

June 11, 2008

First Submitted That Met QC Criteria

June 12, 2008

First Posted (Estimate)

June 13, 2008

Study Record Updates

Last Update Posted (Actual)

November 21, 2017

Last Update Submitted That Met QC Criteria

November 17, 2017

Last Verified

September 1, 2010

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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