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NCT04083716 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Relative Bioavailability and Food Effect of ABI-H2158 in Healthy Adults
A Phase 1 study, sponsored by Assembly Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT04083716: Completed Phase 1 study, sponsored by Assembly Biosciences.
NCT04083716 is a Phase 1 study that has completed, run by Assembly Biosciences. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04083716, a Phase 1 study, has completed, sponsored by Assembly Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study 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.
Interventions
- DRUG ABI-H2158 Reference Formulation
- DRUG ABI-H2158 Test Formulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2019-09-06 |
| Est. Completion | 2019-10-07 |
| Phase | Phase 1 |
What the finished NCT04083716 record still lists
NCT04083716 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 2 interventions - of which ABI-H2158 Reference Formulation is the first listed.
NCT04083716 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04083716 about?
NCT04083716 is a clinical study titled "A Study to Assess the Relative Bioavailability and Food Effect of ABI-H2158 in Healthy Adults". 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.
What is the current status of trial NCT04083716?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2019-09-06. Estimated completion is 2019-10-07.
What interventions are being tested in trial NCT04083716?
The interventions under investigation include: ABI-H2158 Reference Formulation (DRUG), ABI-H2158 Test Formulation (DRUG).
Who is sponsoring clinical trial NCT04083716?
This trial is sponsored by Assembly Biosciences, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04083716's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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