A Study to Assess the Relative Bioavailability and Food Effect of ABI-H2158 in Healthy Adults
NCT04083716 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2019-11-29
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
Interventions
- DRUG
-
ABI-H2158 Reference Formulation
ABI-H2158 tablets Reference Formulation
- DRUG
-
ABI-H2158 Test Formulation
ABI-H2158 tablets Test Formulation
Sponsors & Collaborators
-
Assembly Biosciences
lead INDUSTRY
Principal Investigators
-
Marc Evanchik · Assembly Biosciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-09-06
- Primary Completion
- 2019-10-05
- Completion
- 2019-10-07
- FDA Drug
- Yes
Countries
- United States
Study Locations
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