A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of the ABT-333 Tablet

Study Overview
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Brief Summary
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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.

Official Title
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A Double-Blind, Randomized, Placebo-Controlled Study of the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of ABT-333 in Healthy Adults

Conditions
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HCV Infection

Intervention / Treatment
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* Drug: ABT-333
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1. ABT-333 Tablet<br>Three 400mg ABT-333 Tablets, BID | Drug: ABT-333<br>* See arm description for more information<br>|
| Active Comparator: 2. ABT-333 Tablet<br>Four 400mg ABT-333 Tablets, BID | Drug: ABT-333<br>* See arm description for more information<br>|
| Placebo Comparator: 3. Placebo<br>Three or four placebo tablets, BID | Drug: Placebo<br>* See arm description for more information<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess multiple dose safety and tolerability of an ABT-333 tablet formulation relative to placebo by the evaluation of vital signs, ECGs, physical exams, clinical lab testing and adverse event monitoring. |  | 10 days | 
| Values for the pharmacokinetic parameters of ABT-333 will be evaluated after pre- and post-dose blood draws. |  | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multiple ascending doses (MAD)