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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | 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) |
|
| Group 2 | Experimental | 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) |
|
| Group 3 | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABI-H2158 Reference Formulation | Drug | ABI-H2158 tablets Reference Formulation |
|
| 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 |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Evanchik | Assembly Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | United States |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ABI-H2158 Test Formulation | Drug | ABI-H2158 tablets Test Formulation |
|
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |