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NCT04729101 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Vonoprazan and Lansoprazole in Healthy Participants
A Phase 1 study, sponsored by Phathom Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
NCT04729101: Completed Phase 1 study, sponsored by Phathom Pharmaceuticals.
NCT04729101 is a Phase 1 study that has completed, run by Phathom Pharmaceuticals. The registered enrollment target is 44 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04729101, a Phase 1 study, has completed, sponsored by Phathom Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
Study Summary
To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of vonoprazan (20 mg) and lansoprazole (30 mg) following single (Day 1) and multiple doses (Day 7).
Primary Outcome
Calculated as: Time pH \>4\*100/total actual monitoring period time. Gastric pH was measured continuously over a 24-hour period on Days 1 and 7 of Periods 1 and 2, using a pH and pressure sensitive probe and ambulatory pH recording system. A pH recording was taken every second.
Interventions
- DRUG Vonoprazan
- DRUG Lansoprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2021-01-28 |
| Est. Completion | 2021-06-26 |
| Phase | Phase 1 |
What the finished NCT04729101 record still lists
NCT04729101 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 2 interventions - of which Vonoprazan is the first listed.
NCT04729101 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04729101 about?
NCT04729101 is a clinical study titled "Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Vonoprazan and Lansoprazole in Healthy Participants". To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of vonoprazan (20 mg) and lansoprazole (30 mg) following single (Day 1) and multiple doses (Day 7).
What is the current status of trial NCT04729101?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2021-01-28. Estimated completion is 2021-06-26.
What interventions are being tested in trial NCT04729101?
The interventions under investigation include: Vonoprazan (DRUG), Lansoprazole (DRUG).
Who is sponsoring clinical trial NCT04729101?
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 NCT04729101's enrollment target sits among peer trials
44 1086th of 2000 higher than 901 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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