The purpose of this study is to assess the safety, tolerability and pharmacokinetics of
escalating multiple doses of the ABT-333 tablet formulation in healthy adult subjects.
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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 NCT00909636
Ages eligible for Study
18 Years to 55 Years
Genders eligible for Study
Accepts Healthy Volunteers
overall healthy subjects between the ages of 18 to 55 years old;
if female, subject must be either postmenopausal for at least 2 years or surgically sterile;
females must have negative results for pregnancy tests performed;
if male, subject must be surgically sterile or practicing at least 1 of the following methods of birth control:
partner(s) using IUD,
partner(s) using oral, injected or implanted methods of hormonal contraceptives,
subject and/or partner(s) using double-barrier method;
Body Mass Index is 18 to 29, inclusive
history of significant sensitivity to any drug;
positive test for HAV IgM, HBsAg, HCV Ab or 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;
clinically significant abnormal screening laboratory analyses and ECGs:
ALT > ULN,
AST > ULN,
ECG with QTcF>450 msec in females and >430 msec in males,
or ECG with 2nd or 3rd degree atrioventricular block;
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 or use within the 2-week period prior to the first dose of study drug administration or within 10 half-lives of the respective medication;
use of known inhibitors or inducers of cytochrome P450 3A or cytochrome P450 2C8 within 1 month prior to study drug administration;
positive screen for drugs of abuse, alcohol, or cotinine;
receipt of any drug by injection within 30 days prior to study drug administration;
receipt of any investigational product within a time period equal to 10 half-lives of the product or a minimum of 6 weeks prior to study drug administration;
consumption of alcohol within 48 hours prior to study drug administration;
consumption of grapefruit, grapefruit products, star fruit, or star fruit products within the 72-hour period prior to study drug administration;
consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-333;
history of cardiac disease, including family history of long-QT syndrome or unexplained sudden death.
All locations for NCT00909636
United States (1)
Site Reference ID/Investigator# 20081
Waukegan, Illinois, United States, 60085
View full eligibility
Tris trial is registered with FDA with number: NCT00909636. The sponsor of the trial is Abbott and it is looking for 24 volunteers for the current phase.
Official trial title: A Double-Blind, Randomized, Placebo-Controlled Study of the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of ABT-333 in Healthy Adults
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