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NCT04545944 · ClinicalTrials.gov registry record · Phase 1
Evaluation of Effect of Vonoprazan on Midazolam Pharmacokinetics in Healthy Participants
A Phase 1 study, sponsored by Phathom Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT04545944: Completed Phase 1 study, sponsored by Phathom Pharmaceuticals.
NCT04545944 is a Phase 1 study that has completed, run by Phathom Pharmaceuticals. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04545944, a Phase 1 study, has completed, sponsored by Phathom Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
To determine the time-dependent inhibition potential of repeated doses of oral vonoprazan on the pharmacokinetics (PK) of a single oral dose of midazolam, a sensitive cytochrome P450 3A4 (CYP3A4) substrate, in healthy participants.
Primary Outcome
AUC0-t was measured for midazolam alone on Day 1 and for midazolam administered with vonoprazan on Day 9.
Interventions
- DRUG Midazolam
- DRUG Vonoprazan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-09-15 |
| Est. Completion | 2020-11-25 |
| Phase | Phase 1 |
What the finished NCT04545944 record still lists
NCT04545944 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Midazolam is the first listed.
NCT04545944 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04545944 about?
NCT04545944 is a clinical study titled "Evaluation of Effect of Vonoprazan on Midazolam Pharmacokinetics in Healthy Participants". To determine the time-dependent inhibition potential of repeated doses of oral vonoprazan on the pharmacokinetics (PK) of a single oral dose of midazolam, a sensitive cytochrome P450 3A4 (CYP3A4) substrate, in healthy participants.
What is the current status of trial NCT04545944?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2020-09-15. Estimated completion is 2020-11-25.
What interventions are being tested in trial NCT04545944?
The interventions under investigation include: Midazolam (DRUG), Vonoprazan (DRUG).
Who is sponsoring clinical trial NCT04545944?
This trial is sponsored by Phathom Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04545944's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 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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