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

Assembly Biosciences15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Hepatitis B

Interventions

ABI-H2158 Reference FormulationDRUG

ABI-H2158 tablets Reference Formulation

ABI-H2158 Test FormulationDRUG

ABI-H2158 tablets Test Formulation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Celerion

Tempe, Arizona, United States

Outcomes

Primary Outcomes

Area under the plasma concentration time curve (AUC) of ABI-H2158: Relative Bioavailability and Food Effect

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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