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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04083716

Enrollment

Registered

2019-09-10

Start date

2019-09-06

Completion date

2019-10-07

Last updated

2019-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

Brief summary

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.

Interventions

DRUGABI-H2158 Reference Formulation

ABI-H2158 tablets Reference Formulation

DRUGABI-H2158 Test Formulation

ABI-H2158 tablets Test Formulation

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026