Bioavailability of ABT-333 Tablet Versus First in Human (FIH) Capsule Formulation and Safety, Tolerability and PK Study of Single Doses of ABT-333 in Healthy Volunteers

Study Overview
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Brief Summary
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The purpose of this study is to determine the bioavailability, pharmacokinetic and safety profiles of an experimental Hepatitis C virus (HCV) polymerase inhibitor in healthy volunteers.

Official Title
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An Open-Label Randomized, Crossover Study to Evaluate the Bioavailability of ABT-333 Tablets Versus Capsules, and A Double-blind, Randomized, Crossover Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Single Ascending Doses of ABT-333 Tablets Versus Placebo in Healthy Volunteers

Conditions
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HCV Infection

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: overall healthy subjects; non-childbearing potential females included Exclusion Criteria: 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

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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1. ABT-333 Capsule vs ABT-333 Tablet<br>400mg ABT-333 Tablet, QD, single dose vs eight 50mg ABT-333 Capsules, QD, single dose | Drug: ABT-333 Tablet<br>* See Arm Description for more information.<br>* Other names: ABT-333;Drug: ABT-333 Capsule<br>* See arm description for more information<br>|
| Active Comparator: 2. ABT-333 Tablet<br>ABT-333 400mg Tablet, QD, single ascending doses (1200mg, 1600mg, 2400mg) | Drug: ABT-333 Tablet<br>* See Arm Description for more information.<br>* Other names: ABT-333;Drug: Placebo<br>* See Arm Description for more information.<br>|
| Placebo Comparator: 3. Placebo<br>Placebo tablets, QD, single ascending doses | Drug: ABT-333 Tablet<br>* See Arm Description for more information.<br>* Other names: ABT-333;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 determine relative bioavailability of the ABT-333 tablet formulation compared to the FIH capsule formulation |  | 2 days post dosing | 
| To evaluate single dose safety and tolerability of a ABT-333 tablet formulation relative to placebo |  | 2 days post dosing | 
| To evaluate single dose pharmacokinetics of a ABT-333 tablet formulation |  | 2 days post dosing | 
| Pharmacokinetics |  | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioavailability (BA), Single Ascending Dose (SAD)