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NCT04338711 · ClinicalTrials.gov registry record · Phase 1
A Study In Adult Healthy Volunteers To Asses Once Daily (QD) Dosing With The Selected Age-Appropriate Modified Release (MR) Formulations
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT04338711: Completed Phase 1 study, sponsored by Pfizer.
NCT04338711 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04338711, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the pharmacokinetic (PK) and safety of an age-appropriate tofacitinib Modified Release (MR) formulation with varying level of enteric coating. The effect of food on the PK of age-appropriate tofacitinib MR formulation with the lowest and higher levels of enteric coating will also be assessed.
Primary Outcome
Area Under the Curve From Time Zero to Extrapolated Infinite Time \[AUC (0 - ∞)\]
Interventions
- DRUG tofacitinib modified release (MR)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2020-06-17 |
| Est. Completion | 2020-09-15 |
| Phase | Phase 1 |
What the finished NCT04338711 record still lists
NCT04338711 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 1 intervention - of which tofacitinib modified release (MR) is the first listed.
NCT04338711 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04338711 about?
NCT04338711 is a clinical study titled "A Study In Adult Healthy Volunteers To Asses Once Daily (QD) Dosing With The Selected Age-Appropriate Modified Release (MR) Formulations". The purpose of this study is to evaluate the pharmacokinetic (PK) and safety of an age-appropriate tofacitinib Modified Release (MR) formulation with varying level of enteric coating. The effect of food on the PK of age-appropriate tofacitinib MR formulation with the lowest and higher levels of ente...
What is the current status of trial NCT04338711?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2020-06-17. Estimated completion is 2020-09-15.
What interventions are being tested in trial NCT04338711?
The interventions under investigation include: tofacitinib modified release (MR) (DRUG).
Who is sponsoring clinical trial NCT04338711?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04338711's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 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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