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NCT04083716 Clinical Trial

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

Chronic Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04083716
Other study ID # ABI-H2158-102
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 6, 2019
Est. completion date October 7, 2019

Study information
Verified date November 2019
Source Assembly Biosciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date October 7, 2019
Est. primary completion date October 5, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ABI-H2158 Reference Formulation
ABI-H2158 tablets Reference Formulation
• ABI-H2158 Test Formulation
ABI-H2158 tablets Test Formulation

Locations
Country Name City State
United States Celerion Tempe Arizona

Sponsors (1)
Lead Sponsor Collaborator
Assembly Biosciences

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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