Back to resultsStudy of ABT-333 in Both Healthy Volunteers and Hepatitis C Virus (HCV) + Genotype 1 Infected Subjects
Primary Purpose
HCV Infection
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
ABT-333
Placebo
Sponsored by
About this trial
This is an interventional other trial for HCV Infection
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
1
2
3
Arm Description
Healthy volunteers, receiving 10-1200 mg ABT-333 or placebo, single dose
HCV+ treatment-naive subjects receiving 100-300 mg ABT-333 or placebo, multi-dose, QD or BID
Healthy volunteers, receiving 100 mg ABT-333, multi-dose, food effect
Outcomes
Primary Outcome Measures
Analysis of pharmacokinetic variables and mean change in HCV RNA level from baseline.
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.
Secondary Outcome Measures
Analysis of variance of pharmacokinetic variables for subjects fasting or nonfasting.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00696904
Brief Title
Study of ABT-333 in Both Healthy Volunteers and Hepatitis C Virus (HCV) + Genotype 1 Infected Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
AbbVie
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HCV Infection
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
133 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
Healthy volunteers, receiving 10-1200 mg ABT-333 or placebo, single dose
Arm Title
2
Arm Type
Other
Arm Description
HCV+ treatment-naive subjects receiving 100-300 mg ABT-333 or placebo, multi-dose, QD or BID
Arm Title
3
Arm Type
Other
Arm Description
Healthy volunteers, receiving 100 mg ABT-333, multi-dose, food effect
Intervention Type
Drug
Intervention Name(s)
ABT-333
Intervention Description
Capsule, see arms for intervention description
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsule, see arms for intervention description
Primary Outcome Measure Information:
Title
Analysis of pharmacokinetic variables and mean change in HCV RNA level from baseline.
Time Frame
approximately 1 week or less
Title
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 Outcome Measure Information:
Title
Analysis of variance of pharmacokinetic variables for subjects fasting or nonfasting.
Time Frame
approximately 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
26597291
Citation
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.
Results Reference
result
Learn more about this trial
Study of ABT-333 in Both Healthy Volunteers and Hepatitis C Virus (HCV) + Genotype 1 Infected Subjects
We'll reach out to this number within 24 hrs