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NCT04111614 · ClinicalTrials.gov registry record · Phase 1
A Study to Demonstrate the Equivalence of the Tofacitinib Oral Solution to the Tablet Formulation in Healthy Participants.
A Phase 1 study of Healthy, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT04111614: Completed Phase 1 study of Healthy, sponsored by Pfizer.
NCT04111614 is a Phase 1 study of Healthy that has completed, run by Pfizer. The registered enrollment target is 12 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04111614, a Phase 1 study of Healthy, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase 1, randomized, open label, 2 period, 2 sequence, cross over, single dose study to evaluate the AUC equivalence, and safety of tofacitinib 5 mL oral solution (1 mg/mL) and 5 mg tablet in healthy participants. Participants will be randomized to 1 of the 2 treatment sequences. A total of approximately 12 healthy male and/or female (non-childbearing potential) participants will be enrolled in the study so that approximately 6 participants will be enrolled in each treatment sequence. Each treatment sequence will consist of 2 periods. In both sequences, participants will remain in the CRU for a total of 5 days and 4 nights (including Period 1 and Period 2).
Primary Outcome
Area under the curve from time zero to extrapolated infinite time for both oral solution and tofacitinib.
Conditions Studied
Interventions
- DRUG Tofacitinib tablet
- DRUG Tofacitinib Oral Solution
Study Locations (1)
Connecticut
- New Haven Clinical Research Unit - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2019-10-11 |
| Est. Completion | 2019-12-12 |
| Phase | Phase 1 |
What the finished NCT04111614 record still lists
NCT04111614 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Tofacitinib tablet is the first listed.
NCT04111614 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT04111614 about?
NCT04111614 is a clinical study titled "A Study to Demonstrate the Equivalence of the Tofacitinib Oral Solution to the Tablet Formulation in Healthy Participants.". This is a Phase 1, randomized, open label, 2 period, 2 sequence, cross over, single dose study to evaluate the AUC equivalence, and safety of tofacitinib 5 mL oral solution (1 mg/mL) and 5 mg tablet in healthy participants. Participants will be randomized to 1 of the 2 treatment sequences. A total o...
What is the current status of trial NCT04111614?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2019-10-11. Estimated completion is 2019-12-12.
What conditions does trial NCT04111614 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT04111614?
The interventions under investigation include: Tofacitinib tablet (DRUG), Tofacitinib Oral Solution (DRUG).
Who is sponsoring clinical trial NCT04111614?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04111614 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04111614's enrollment target sits among peer trials
12 996th of 1090 higher than 61 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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.
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