Status:
COMPLETED
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of the ABT-333 Tablet
Lead Sponsor:
Abbott
Conditions:
HCV Infection
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00909636
Start Date
May 1 2009
Last Update
October 13 2010
Active Locations (1)
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1
Site Reference ID/Investigator# 20081
Waukegan, Illinois, United States, 60085