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
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Sep 2019
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2019
CompletedStudy Start
First participant enrolled
September 6, 2019
CompletedFirst Posted
Study publicly available on registry
September 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 5, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 7, 2019
CompletedNovember 29, 2019
November 1, 2019
29 days
September 6, 2019
November 26, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (3)
Group 1
EXPERIMENTALABI-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
EXPERIMENTALABI-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
EXPERIMENTALABI-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)
Interventions
Eligibility Criteria
You may qualify if:
- \. No clinically significant abnormal findings on physical exam, medical history, or clinical laboratory results at screening.
You may not qualify if:
- Positive test results for human immunodeficiency virus (HIV) or hepatitis B or C.
- Treatment for drug or alcohol dependence.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Celerion
Tempe, Arizona, 85283, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Marc Evanchik
Assembly Biosciences
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2019
First Posted
September 10, 2019
Study Start
September 6, 2019
Primary Completion
October 5, 2019
Study Completion
October 7, 2019
Last Updated
November 29, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share