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NCT03112148 · ClinicalTrials.gov registry record · Phase 1
PK Study in Adult Healthy Volunteers to Assess QD Dosing With the Selected Age-appropriate MR Formulations
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT03112148: Completed Phase 1 study, sponsored by Pfizer.
NCT03112148 is a Phase 1 study that has completed, run by Pfizer. 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
NCT03112148, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This is a Phase 1, randomized, open label, 4-period, 6-sequence, partial cross-over, single-dose study to evaluate the PK of age-appropriate tofacitinib MR formulations (release rates: MR-Slow, MR-Moderate, and MR-Fast) compared to tofacitinib IR solution under fasting conditions. The effect of food on the PK of MR-Slow and MR-Fast will also be assessed.
Primary Outcome
Area Under the Curve From Time Zero to Extrapolated Infinite Time \[AUC (0 - ∞)\]
Interventions
- DRUG 10 mg dose MR formulations,10 mg dose of tofacitinib IR solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2017-09-11 |
| Est. Completion | 2017-11-15 |
| Phase | Phase 1 |
What the finished NCT03112148 record still lists
NCT03112148 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 10 mg dose MR formulations,10 mg dose of tofacitinib IR solution is the first listed.
NCT03112148 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03112148 about?
NCT03112148 is a clinical study titled "PK Study in Adult Healthy Volunteers to Assess QD Dosing With the Selected Age-appropriate MR Formulations". This is a Phase 1, randomized, open label, 4-period, 6-sequence, partial cross-over, single-dose study to evaluate the PK of age-appropriate tofacitinib MR formulations (release rates: MR-Slow, MR-Moderate, and MR-Fast) compared to tofacitinib IR solution under fasting conditions. The effect of food...
What is the current status of trial NCT03112148?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2017-09-11. Estimated completion is 2017-11-15.
What interventions are being tested in trial NCT03112148?
The interventions under investigation include: 10 mg dose MR formulations,10 mg dose of tofacitinib IR solution (DRUG).
Who is sponsoring clinical trial NCT03112148?
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 NCT03112148'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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