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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 is a Phase 1 study that has completed, run by Phathom Pharmaceuticals. The registered enrollment target is 20 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04545944
The ClinicalTrials.gov registry entry for NCT04545944 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Phathom Pharmaceuticals, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Midazolam is the first listed.
NCT04545944 reports 0 study locations.
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.
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