A Study to Assess the Relative Bioavailability and Food Effect of ABI-H2158 in Healthy Adults

Study Overview
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Brief Summary
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This study is designed to assess the relative bioavailability of ABI-H2158 tablets (Test Formulation) compared to ABI-H2158 tablets (Reference Formulation). The effect of food on the pharmacokinetics of the Test Formulation will also be evaluated under fed and fasting conditions.

Official Title
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A Phase 1, Open-Label, Randomized, 3-Way Crossover Study to Assess the Relative Bioavailability and Food Effect of ABI-H2158 in Healthy Adult Subjects

Conditions
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Chronic Hepatitis B

Intervention / Treatment
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* Drug: ABI-H2158 Reference Formulation
* Drug: ABI-H2158 Test Formulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. No clinically significant abnormal findings on physical exam, medical history, or clinical laboratory results at screening. Exclusion Criteria: Positive test results for human immunodeficiency virus (HIV) or hepatitis B or C. Treatment for drug or alcohol dependence.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>ABI-H2158 Reference Formulation in a fasting state on Day 1 (Period 1), then ABI-H2158 Test Formulation in a fasting state on Day 8 (Period 2), then ABI-H2158 Test Formulation after a high-fat meal on Day 15 (Period 3) | Drug: ABI-H2158 Reference Formulation<br>* ABI-H2158 tablets Reference Formulation<br>Drug: ABI-H2158 Test Formulation<br>* ABI-H2158 tablets Test Formulation<br>|
| Experimental: Group 2<br>ABI-H2158 Test Formulation in a fasting state on Day 1 (Period 1), then ABI-H2158 Test Formulation after a high-fat meal on Day 8 (Period 2), then ABI-H2158 Reference Formulation in a fasting state on Day 15 (Period 3) | Drug: ABI-H2158 Reference Formulation<br>* ABI-H2158 tablets Reference Formulation<br>Drug: ABI-H2158 Test Formulation<br>* ABI-H2158 tablets Test Formulation<br>|
| Experimental: Group 3<br>ABI-H2158 Test Formulation after a high-fat meal on Day 1 (Period 1), then ABI-H2158 Reference Formulation in a fasting state on Day 8 (Period 2), then ABI-H2158 Test Formulation in a fasting state on Day 15 (Period 3) | Drug: ABI-H2158 Reference Formulation<br>* ABI-H2158 tablets Reference Formulation<br>Drug: ABI-H2158 Test Formulation<br>* ABI-H2158 tablets Test Formulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration time curve (AUC) of ABI-H2158: Relative Bioavailability and Food Effect |  | before dosing and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, 48, 72, 96, and 120 hours after dosing on Days 1, 8, and 15 | 
| Maximum observed plasma concentration (Cmax) of ABI-H2158: Relative Bioavailability and Food Effect |  | before dosing and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, 48, 72, 96, and 120 hours after dosing on Days 1, 8, and 15 |