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NCT04142762 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess CYP3A4 Modulator, Oral Contraceptive, and pH Modifier Drug Interactions for ABI-H2158 in Healthy Adults
A Phase 1 study, sponsored by Assembly Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
NCT04142762: Completed Phase 1 study, sponsored by Assembly Biosciences.
NCT04142762 is a Phase 1 study that has completed, run by Assembly Biosciences. The registered enrollment target is 80 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04142762, a Phase 1 study, has completed, sponsored by Assembly Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
Study Summary
This study is designed to assess 1) the effect of multiple doses of itraconazole (CYP3A4 inhibitor), rifampin (CYP3A4 inducer), and esomeprazole (pH modifier) on the pharmacokinetics of a single oral dose of ABI-H2158, and 2) the effect of steady-state oral ABI-H2158 on the pharmacokinetics of midazolam (sedative) and levonorgestrel/ethinyl estradiol (active oral contraceptive) in healthy adult participants.
Interventions
- DRUG Midazolam
- DRUG Rifampin
- DRUG Itraconazole
- DRUG ABI-H2158
- DRUG Ethinyl Estradiol / Levonorgestrel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2019-10-18 |
| Est. Completion | 2020-01-29 |
| Phase | Phase 1 |
What the finished NCT04142762 record still lists
NCT04142762 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher).
The record links to 0 conditions, and to 5 interventions - of which Midazolam is the first listed.
NCT04142762 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04142762 about?
NCT04142762 is a clinical study titled "A Study to Assess CYP3A4 Modulator, Oral Contraceptive, and pH Modifier Drug Interactions for ABI-H2158 in Healthy Adults". This study is designed to assess 1) the effect of multiple doses of itraconazole (CYP3A4 inhibitor), rifampin (CYP3A4 inducer), and esomeprazole (pH modifier) on the pharmacokinetics of a single oral dose of ABI-H2158, and 2) the effect of steady-state oral ABI-H2158 on the pharmacokinetics of midaz...
What is the current status of trial NCT04142762?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2019-10-18. Estimated completion is 2020-01-29.
What interventions are being tested in trial NCT04142762?
The interventions under investigation include: Midazolam (DRUG), Rifampin (DRUG), Itraconazole (DRUG), ABI-H2158 (DRUG), Ethinyl Estradiol / Levonorgestrel (DRUG).
Who is sponsoring clinical trial NCT04142762?
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 NCT04142762's enrollment target sits among peer trials
80 672nd of 2000 higher than 1,305 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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