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NCT05343364 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Vonoprazan in Adolescents With Symptomatic Gastroesophageal Reflux Disease
A Phase 1 study, sponsored by Phathom Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT05343364: Completed Phase 1 study, sponsored by Phathom Pharmaceuticals.
NCT05343364 is a Phase 1 study that has completed, run by Phathom Pharmaceuticals. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05343364, a Phase 1 study, has completed, sponsored by Phathom Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the pharmacokinetic profile of vonoprazan in adolescent participants with symptomatic gastroesophageal reflux disease (GERD).
Primary Outcome
Plasma pharmacokinetic (PK) parameters were estimated using a non-linear mixed effects model and were determined from the concentration-time data for all evaluable participants. Actual sampling times, rather than scheduled or nominal sampling times, were used in all computations using sampling time.
Interventions
- DRUG Vonoprazan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2022-05-09 |
| Est. Completion | 2023-06-13 |
| Phase | Phase 1 |
What the finished NCT05343364 record still lists
NCT05343364 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 1 intervention - of which Vonoprazan is the first listed.
NCT05343364 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05343364 about?
NCT05343364 is a clinical study titled "A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Vonoprazan in Adolescents With Symptomatic Gastroesophageal Reflux Disease". The primary objective of this study is to evaluate the pharmacokinetic profile of vonoprazan in adolescent participants with symptomatic gastroesophageal reflux disease (GERD).
What is the current status of trial NCT05343364?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2022-05-09. Estimated completion is 2023-06-13.
What interventions are being tested in trial NCT05343364?
The interventions under investigation include: Vonoprazan (DRUG).
Who is sponsoring clinical trial NCT05343364?
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 NCT05343364's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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