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NCT04903093 · ClinicalTrials.gov registry record · Phase 1
A Study Evaluating Relative Bioavailability of an Oral Suspension of Abrocitinib and Effect of an Acid Reducing Agent on the Bioavailability of Abrocitinib and Assessing the Taste of Abrocitinib Oral Formulations.
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT04903093: Completed Phase 1 study, sponsored by Pfizer.
NCT04903093 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04903093, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
This study consists of 2 parts: Part A is to estimate the relative bioavailability of a single 200 mg dose of abrocitinib oral suspension (Test formulation) compared to the commercial abrocitinib tablet (200 mg) (Reference formulation). The effect of an acid-reducing agent on the pharmacokinetics of abrocitinib and its metabolites will also be evaluated by administering abrocitinib 200 mg commercial tablet with or without famotidine 40 mg, as an acid-reducing agent. Part B is to assess the taste and palatability of six different abrocitinib oral suspension formulations. Additionally, the safety and tolerability of abrocitinib tablet (in Part A) and abrocitinib oral suspension formulations (in Part B) will be assessed when given with or without famotidine 40 mg once daily.
Primary Outcome
Area under the plasma concentration time profile from time 0 extrapolated to infinity (AUCinf) was measured. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Interventions
- DRUG Abrocitinib tablet
- DRUG Abrocitinib Suspension F1
- DRUG Abrocitinib Suspension F2
- DRUG Abrocitinib Suspension F3
- DRUG Abrocitinib Suspension F4
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2021-06-04 |
| Est. Completion | 2021-10-26 |
| Phase | Phase 1 |
What the finished NCT04903093 record still lists
NCT04903093 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 5 interventions - of which Abrocitinib tablet is the first listed.
NCT04903093 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04903093 about?
NCT04903093 is a clinical study titled "A Study Evaluating Relative Bioavailability of an Oral Suspension of Abrocitinib and Effect of an Acid Reducing Agent on the Bioavailability of Abrocitinib and Assessing the Taste of Abrocitinib Oral Formulations.". This study consists of 2 parts: Part A is to estimate the relative bioavailability of a single 200 mg dose of abrocitinib oral suspension (Test formulation) compared to the commercial abrocitinib tablet (200 mg) (Reference formulation). The effect of an acid-reducing agent on the pharmacokinetics of...
What is the current status of trial NCT04903093?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2021-06-04. Estimated completion is 2021-10-26.
What interventions are being tested in trial NCT04903093?
The interventions under investigation include: Abrocitinib tablet (DRUG), Abrocitinib Suspension F1 (DRUG), Abrocitinib Suspension F2 (DRUG), Abrocitinib Suspension F3 (DRUG), Abrocitinib Suspension F4 (DRUG).
Who is sponsoring clinical trial NCT04903093?
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 NCT04903093's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 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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