The purpose of this study is to evaluate the effect of food on pharmacokinetics, safety and
tolerability of an experimental Hepatitis C Virus (HCV) protease inhibitor with ritonavir in
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT00909311
Ages eligible for Study
18 Years to 55 Years
Genders eligible for Study
Accepts Healthy Volunteers
overall healthy subjects;
non-childbearing potential females included
history of significant sensitivity to any drug;
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
All locations for NCT00909311
United States (1)
Site Reference ID/Investigator# 19421
Waukegan, Illinois, United States, 60085
View full eligibility
Tris trial is registered with FDA with number: NCT00909311. The sponsor of the trial is Abbott and it is looking for 8 volunteers for the current phase.
Official trial title: Randomized, Open-label, 2-period Cross-over Study in Healthy Adults to Evaluate the Effect of Food on Pharmacokinetics, Safety and Tolerability of ABT-450 With Ritonavir
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