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

Primary Purpose

Chronic Hepatitis B

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

ABI-H2158 Reference Formulation

ABI-H2158 Test Formulation

About this trial

This is an interventional treatment trial for Chronic Hepatitis B

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Celerion

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Group 1

Group 2

Group 3

Arm 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)

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)

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)

Outcomes

Primary Outcome Measures

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

Maximum observed plasma concentration (Cmax) of ABI-H2158: Relative Bioavailability and Food Effect

Secondary Outcome Measures

Full Information

NCT ID

NCT04083716

First Posted

September 6, 2019

Last Updated

November 26, 2019

Sponsor

Assembly Biosciences

1. Study Identification

Unique Protocol Identification Number

NCT04083716

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

September 6, 2019 (Actual)

Primary Completion Date

October 5, 2019 (Actual)

Study Completion Date

October 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assembly Biosciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis B

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

Arm Title

Group 2

Arm Type

Experimental

Arm Description

Arm Title

Group 3

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

ABI-H2158 Reference Formulation

Intervention Description

ABI-H2158 tablets Reference Formulation

Intervention Type

Drug

Intervention Name(s)

ABI-H2158 Test Formulation

Intervention Description

ABI-H2158 tablets Test Formulation

Primary Outcome Measure Information:

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 1. No clinically significant abnormal findings on physical exam, medical history, or clinical laboratory results at screening. Exclusion Criteria: Positive test results for human immunodeficiency virus (HIV) or hepatitis B or C. Treatment for drug or alcohol dependence.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marc Evanchik

Organizational Affiliation

Assembly Biosciences

Official's Role

Study Director

Facility Information:

Facility Name

Celerion

City

Tempe

State/Province

Arizona

ZIP/Postal Code

85283

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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