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

NCT04083716 — Phase 1, Completed, 15 participants, Assembly Biosciences
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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

RegistryNCT04083716
StatusCompleted
PhasePhase 1
Study typeInterventional; randomized, crossover, masking: none, treatment
Enrollment15 (Actual)
SponsorAssembly Biosciences (Industry)
ConditionsChronic Hepatitis B
InterventionsABI-H2158 Reference Formulation, ABI-H2158 Test Formulation (Drug)
Datesstart 2019-09-06, primary completion 2019-10-05, completion 2019-10-07, first posted 2019-09-10, last updated 2019-11-29
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Chronic Hepatitis B All trials of ABI-H2158 Reference Formulation All trials of ABI-H2158 Test Formulation

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Group 1ExperimentalDrug: ABI-H2158 Reference Formulation; Drug: ABI-H2158 Test FormulationABI-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 2ExperimentalDrug: ABI-H2158 Reference Formulation; Drug: ABI-H2158 Test FormulationABI-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 3ExperimentalDrug: ABI-H2158 Reference Formulation; Drug: ABI-H2158 Test FormulationABI-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)
  • ABI-H2158 Reference Formulation (Drug): ABI-H2158 tablets Reference Formulation
  • ABI-H2158 Test Formulation (Drug): ABI-H2158 tablets Test Formulation

+Outcome measures

Primary outcomes

  • 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]

+Eligibility

Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers

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.

+Locations (1)

FacilityCityCountryStatus
CelerionTempe, ArizonaUnited States

+Investigators