Evaluation of the Bioavailability of Two ABT-072 Tablet Formulations as Compared to ABT-072 Capsule Formulation

Study Overview
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Brief Summary
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The purpose of this study is to assess the bioavailability, safety, tolerability and pharmacokinetics of two tablet formulations as compared to the capsule formulation suspended in liquid.

Detailed Description
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A single-dose, three period, complete cross-over study to evaluate the relative bioavailability, pharmacokinetics, safety and tolerability of two candidate tablet formulations of ABT-072 when compared to that of the original capsule formulation suspended in liquid as a reference.

Official Title
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An Open-Label, Randomized, Crossover Study to Evaluate the Bioavailability of Two Candidate Tablet Formulations of ABT-072 With Reference to the Capsule Formulation

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: ABT-072


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overall healthy subjects, non-childbearing females included. Exclusion Criteria: Use of any medications (prescription and over-the-counter), vitamins, or herbal supplements within the 2-week period prior to the first dose of study drug administration or within 10 half-lives of the respective medication, whichever is longer. Pregnant or breast-feeding female. Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or HIV antibodies (HIV Ab). Positive screen for drugs of abuse, alcohol, or cotinine. 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 within the 6-month period preceding study drug administration.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tablet 1 vs. Capsule<br>Single dose of 2 x 50 mg tablets (Tablet 1) vs. 100 mg ABT-072 (contents of capsules) suspended in liquid. | Drug: ABT-072<br>* See arm description for more information<br>|
| Active Comparator: Tablet 2 vs. Capsule<br>Single dose of 2 x 50 mg tablets (Tablet 2) vs. 100 mg ABT-072 (contents from capsules) suspended in liquid. | Drug: ABT-072<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 evaluate the relative bioavailability of two candidate tablet formulations of ABT-072 to that of the capsule formulation. |  | 4 days post each dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate safety and tolerability of two candidate tablet formulations of ABT-072 to that of the capsule formulation. |  | Through 14 days post last dose. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 1, Bioavailability