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

Assembly Biosciences

Status and phase: Completed; Phase 1

Conditions: Chronic Hepatitis B

Treatments: Drug: ABI-H2158 Test Formulation; Drug: ABI-H2158 Reference Formulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT04083716

ABI-H2158-102

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. No clinically significant abnormal findings on physical exam, medical history, or clinical laboratory results at screening.

Exclusion criteria

1. Positive test results for human immunodeficiency virus (HIV) or hepatitis B or C.
2. Treatment for drug or alcohol dependence.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 3 patient groups

Group 1

Experimental group

Description:

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)

Treatment:

Drug: ABI-H2158 Reference Formulation

Drug: ABI-H2158 Test Formulation

Group 2

Experimental group

Description:

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)

Treatment:

Drug: ABI-H2158 Reference Formulation

Drug: ABI-H2158 Test Formulation

Group 3

Experimental group

Description:

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)

Treatment:

Drug: ABI-H2158 Reference Formulation

Drug: ABI-H2158 Test Formulation