Single and Multiple Dose Evaluation of ABT-072 and to Evaluate the Effect of Food on the Pharmacokinetics of ABT-072

Study Overview
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Brief Summary
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To assess the safety, tolerability and pharmacokinetics of the ABT-072 tablet formulation administered as a single dose and then administered as multiple doses for 7 days. The effect of food on the safety, tolerability and pharmacokinetics of the ABT-072 tablet will also be evaluated.

Detailed Description
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The study consists of two substudies. Substudy 1 is a two-period, single ascending dose (SAD) and multiple ascending dose (MAD) blinded, randomized, placebo-controlled, non-fasting study. Designated groups that participate in Period 1 (SAD) will also participate in Period 2 (MAD). Substudy 2 is an open-label, randomized two-period, crossover study to examine the effect of food on the pharmacokinetics of ABT 072.

Official Title
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A Blinded, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profiles of Single and Multiple Doses (7 Days) of ABT-072 and an Open-label Study to Evaluate the Effect of Food on the Pharmacokinetic

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: ABT-072
* Drug: Placebo


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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>ABT-072 tablet single ascending dose | Drug: ABT-072<br>* See Arms information for a detailed description.<br>|
| Experimental: 2<br>Placebo tablet | Drug: Placebo<br>* See Arms information for a detailed description.<br>|
| Experimental: 3<br>ABT-072 tablet administered under non-fasting conditions. | Drug: ABT-072<br>* See Arms information for a detailed description.<br>|
| Experimental: 4<br>ABT-072 tablet administered under fasting conditions | Drug: ABT-072<br>* See Arms information for a detailed description.<br>|
| Experimental: 5<br>ABT-072 tablet multiple ascending dose | Drug: ABT-072<br>* See Arms information for a detailed description.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the single and multiple dose safety and tolerability of the ABT-072 tablet formulation under non-fasting conditions. |  | Up to 14 days post last dose. | 
| To determine the single and multiple dose safety pharmacokinetics of the ABT-072 tablet formulation under non-fasting conditions. |  | 72 hours post last dose. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the effect of food on the pharmacokinetics of the ABT-072 tablet formulation. |  | 72 hours post last dose. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 1, Single and Multiple Ascending Dose, Food Effect