NCT04083716

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Assembly Biosciences · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	ABI-H2158 Reference Formulation	ABI-H2158 tablets Reference Formulation
DRUG	ABI-H2158 Test Formulation	ABI-H2158 tablets Test Formulation

Timeline

• Start date: 2019-09-06
• Primary completion: 2019-10-05
• Completion: 2019-10-07
• First posted: 2019-09-10
• Last updated: 2019-11-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study