Study of ABT-333 in Both Healthy Volunteers and Hepatitis C Virus (HCV) + Genotype 1 Infected Subjects
NCT ID: NCT00696904
Last Updated: 2017-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
133 participants
INTERVENTIONAL
2008-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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1
Healthy volunteers, receiving 10-1200 mg ABT-333 or placebo, single dose
ABT-333
Capsule, see arms for intervention description
Placebo
Capsule, see arms for intervention description
2
HCV+ treatment-naive subjects receiving 100-300 mg ABT-333 or placebo, multi-dose, QD or BID
ABT-333
Capsule, see arms for intervention description
Placebo
Capsule, see arms for intervention description
3
Healthy volunteers, receiving 100 mg ABT-333, multi-dose, food effect
ABT-333
Capsule, see arms for intervention description
Interventions
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ABT-333
Capsule, see arms for intervention description
Placebo
Capsule, see arms for intervention description
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Abbott
Countries
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References
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Mensing S, Polepally AR, Konig D, Khatri A, Liu W, Podsadecki TJ, Awni WM, Menon RM, Dutta S. Population Pharmacokinetics of Paritaprevir, Ombitasvir, Dasabuvir, Ritonavir, and Ribavirin in Patients with Hepatitis C Virus Genotype 1 Infection: Combined Analysis from 9 Phase 1b/2 Studies. AAPS J. 2016 Jan;18(1):270-80. doi: 10.1208/s12248-015-9846-1. Epub 2015 Nov 23.
Other Identifiers
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M10-351
Identifier Type: -
Identifier Source: org_study_id