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

Phase 1

Completed

• Conditions: Chronic Hepatitis B
• Interventions: Drug: ABI-H2158 Reference Formulation; Drug: ABI-H2158 Test Formulation

• Registration Number: NCT04083716
• Lead Sponsor: Assembly Biosciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-06
• Study First Submitted: 2019-09-06
• Study First Submitted QC: 2019-09-06
• Study First Posted: 2019-09-10
• Primary Completion: 2019-10-05
• Study Completion: 2019-10-07
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-26
• Last Update Posted: 2019-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1	ABI-H2158 Reference Formulation	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 1	ABI-H2158 Test Formulation	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 2	ABI-H2158 Reference Formulation	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 2	ABI-H2158 Test Formulation	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 3	ABI-H2158 Reference Formulation	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 3	ABI-H2158 Test Formulation	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)

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Celerion; 🇺🇸 Tempe, Arizona, United States