A Study of ABT-072 in Healthy and Hepatitis C Virus Genotype 1-Infected Adults

October 19, 2010 updated by: Abbott
To evaluate the safety, tolerability and pharmacokinetics of ABT-072 in healthy volunteers and its anti-viral activity in HCV infected subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A blinded, randomized, placebo-controlled trial to study the safety, tolerability, antiviral activity and pharmacokinetic profiles of ABT-072 in healthy and HCV genotype-1 infected adults.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Abbott Park, Illinois, United States, 60064
        • Global Medical Information

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Criteria for Healthy Adults:

  • Informed consent has been obtained
  • Subject is in general good health
  • If female, then postmenopausal
  • If female, then not pregnant
  • If male, must be surgically sterile or both he and the partner must use birth control
  • Body Mass Index is 18 to 29, inclusive

Criteria for HCV-infected Adults:

  • Infected with HCV for at least 6 months as shown by either detectable HCV RNA or reactive antibody, or liver biopsy with pathology indicative of HCV infection, or disclosure of a risk factor
  • Subject is infected with HCV genotype 1 with detectable HCV RNA of > 50,000 IU/mL

Exclusion Criteria:

Criteria for Healthy Adults:

  • If female, then pregnant or breast feeding
  • Positive HAV-IgM, HBs-Ag, HCV Ab or HIV Ab
  • Within 6 months of start of study, drug or alcohol abuse and use of nicotine products
  • Alcohol intake within 48 hours prior to study drug administration

Criteria for HCV-infected Adults:

  • Need for prescription or over-the-counter medication
  • Child Pugh score > 5 or clinical evidence of cirrhosis
  • No other cause for liver disease other than HCV infection
  • ALT or AST > 4 x ULN
  • Creatinine > ULN
  • Clinically significant abnormal ECG
  • HCV RNA levels above the level of assay quantification
  • TSH values outside normal range

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
Single dose of ABT-072, dose escalation ranging from 10 mg to 320 mg or placebo in healthy volunteers
Drug: ABT-072
Capsule or powder drug substance from the capsule mixed in an alternative vehicle. For additional information refer to Arm Description.
Drug: placebo
Capsule, or powder drug substance from the capsule mixed in an alternative vehicle. For additional information refer to Arm Description.
Other: 2
HCV positive subjects administered 160mg ABT-072 or placebo, multi-dose, QD
Drug: ABT-072
Capsule or powder drug substance from the capsule mixed in an alternative vehicle. For additional information refer to Arm Description.
Drug: placebo
Capsule, or powder drug substance from the capsule mixed in an alternative vehicle. For additional information refer to Arm 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: 2 weeks
2 weeks
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: 2 weeks
2 weeks

Collaborators and Investigators

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

Sponsor

Abbott

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

September 1, 2008

Primary Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

September 12, 2008

First Submitted That Met QC Criteria

September 12, 2008

First Posted (Estimate)

September 15, 2008

Study Record Updates

Last Update Posted (Estimate)

October 21, 2010

Last Update Submitted That Met QC Criteria

October 19, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M10-573

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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