- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00696904
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
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M10-351
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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