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

NCT ID: NCT04083716

Last Updated: 2019-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-06

Study Completion Date

2019-10-07

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.

Detailed Description

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Conditions

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Chronic Hepatitis B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 3

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)

Group Type EXPERIMENTAL

ABI-H2158 Reference Formulation

Intervention Type DRUG

ABI-H2158 tablets Reference Formulation

ABI-H2158 Test Formulation

Intervention Type DRUG

ABI-H2158 tablets Test Formulation

Group 1

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 Type EXPERIMENTAL

ABI-H2158 Reference Formulation

Intervention Type DRUG

ABI-H2158 tablets Reference Formulation

ABI-H2158 Test Formulation

Intervention Type DRUG

ABI-H2158 tablets Test Formulation

Group 2

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 Type EXPERIMENTAL

ABI-H2158 Reference Formulation

Intervention Type DRUG

ABI-H2158 tablets Reference Formulation

ABI-H2158 Test Formulation

Intervention Type DRUG

ABI-H2158 tablets Test Formulation

Interventions

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ABI-H2158 Reference Formulation

ABI-H2158 tablets Reference Formulation

Intervention Type DRUG

ABI-H2158 Test Formulation

ABI-H2158 tablets Test Formulation

Intervention Type DRUG

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

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

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assembly Biosciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc Evanchik

Role: STUDY_DIRECTOR

Assembly Biosciences

Locations

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Celerion

Tempe, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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ABI-H2158-102

Identifier Type: -

Identifier Source: org_study_id