Safety, Tolerability and PK Study of Single Doses of ABT-450 With and Without Ritonavir to Treat Hepatitis C Virus (HCV) Genotype 1
NCT ID: NCT00850044
Last Updated: 2017-11-20
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
87 participants
INTERVENTIONAL
2009-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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1
ABT-450
ABT-450
capsules,QD, one dose, see Arm Descriptions for more information
2
Placebo for ABT-450
placebo for ABT-450
capsules, QD, one dose
3
ABT-450/ritonavir
ABT-450
capsules,QD, one dose, see Arm Descriptions for more information
ritonavir
capsules, QD, one dose, escalating doses, see Arm Descriptions for more information
4
Placebo for ABT-450/placebo for ritonavir
placebo for ABT-450
capsules, QD, one dose
Placebo for ritonavir
capsules, QD, one dose
Interventions
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ABT-450
capsules,QD, one dose, see Arm Descriptions for more information
ritonavir
capsules, QD, one dose, escalating doses, see Arm Descriptions for more information
placebo for ABT-450
capsules, QD, one dose
Placebo for ritonavir
capsules, QD, one dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* non-childbearing potential females included
Exclusion Criteria
* positive test for HAV IgM, HBsAg, anti-HCV Ab or anti-HIV Ab
* history of gastrointestinal issues or procedures
* history of seizures, diabetes or cancer (except basal cell carcinoma)
* clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder
* use of tobacco or nicotine-containing products with the 6-month period prior to study drug administration
* donation or loss of 550 mL or more blood volume or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration
* abnormal screening laboratory results that are considered clinically significant by the investigator
* current enrollment in another clinical study
* previous enrollment in this study
* recent (6-month) history of drug/alcohol abuse that could preclude adherence to the protocol
* pregnant or breastfeeding female
* requirement for any OTC and/or prescription medication, vitamins and/or herbal supplements on a regular basis
18 Years
55 Years
ALL
Yes
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Abbott
Principal Investigators
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Adebayo A Lawal, MD
Role: STUDY_DIRECTOR
Abbott
Locations
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Site Reference ID/Investigator# 15981
Waukegan, Illinois, United States
Countries
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References
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Menon RM, Klein CE, Podsadecki TJ, Chiu YL, Dutta S, Awni WM. Pharmacokinetics and tolerability of paritaprevir, a direct acting antiviral agent for hepatitis C virus treatment, with and without ritonavir in healthy volunteers. Br J Clin Pharmacol. 2016 May;81(5):929-40. doi: 10.1111/bcp.12873. Epub 2016 Feb 24.
Other Identifiers
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M10-749
Identifier Type: -
Identifier Source: org_study_id