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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 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 19 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04903093
The ClinicalTrials.gov registry entry for NCT04903093 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Abrocitinib tablet is the first listed.
NCT04903093 reports 0 study locations.
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.
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