Study in Healthy Adults to Evaluate Effect of Food on Pharmacokinetics, Safety and Tolerability of ABT-450 With Ritonavir
NCT ID: NCT00909311
Last Updated: 2010-10-13
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
8 participants
INTERVENTIONAL
2009-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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1
Non-fasting
ABT-450
capsules, QD, 1 dose in each cross-over period
ritonavir
capsule, QD, 1 dose in each cross-over period
2
Fasting
ABT-450
capsules, QD, 1 dose in each cross-over period
ritonavir
capsule, QD, 1 dose in each cross-over period
Interventions
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ABT-450
capsules, QD, 1 dose in each cross-over period
ritonavir
capsule, QD, 1 dose in each cross-over period
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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Abbott
INDUSTRY
Responsible Party
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Abbott
Principal Investigators
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Isabelle A Gaultier, M.S., IBMH
Role: STUDY_DIRECTOR
Abbott
Locations
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Site Reference ID/Investigator# 19421
Waukegan, Illinois, United States
Countries
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Other Identifiers
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M10-923
Identifier Type: -
Identifier Source: org_study_id