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NCT05067439 · ClinicalTrials.gov registry record · Phase 1
A Study to Estimate the Effect of Multiple Dose Abrocitinib on Caffeine, Efavirenz, and Omeprazole in Healthy Participants
A Phase 1 study of Healthy Participants, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT05067439: Completed Phase 1 study of Healthy Participants, sponsored by Pfizer.
NCT05067439 is a Phase 1 study of Healthy Participants that has completed, run by Pfizer. The registered enrollment target is 26 participants, below the 65-participant average among 119 other Healthy Participants trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05067439, a Phase 1 study of Healthy Participants, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase 1, open-label, multiple dose, single fixed-sequence, 2-period study to evaluate the effect of abrocitinib on the pharmacokinetics (PK) of caffeine, efavirenz and omeprazole in healthy adult participants. A total of approximately 13 healthy male and/or female participants will be enrolled in the study to obtain at least 12 evaluable participants who complete the study. Participants who withdraw from the study or are considered non-evaluable may be replaced at the discretion of the sponsor. Participants will be screened within 28 days of the first dose of study intervention. Participants will have a phone contact 3 days prior to Day 1 dosing (Day -3) in Period 1 as a reminder to abstain from caffeine-containing products. Participants will be admitted to the clinical research unit (CRU) at least 24 hours prior to Day 1 dosing (Day 1) in Period 1. Participants will remain in the CRU for a total of 15 days and 14 nights. Participants will have a telephone contact between 28-35 calendar days after the last administration of the investigational product.
Primary Outcome
AUCinf was defined as area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
Conditions Studied
Interventions
- DRUG Abrocitinib
- DRUG Omeprazole
- DRUG Caffeine
- DRUG Efavirenz
Study Locations (1)
Florida
- Research Centers of America ( Hollywood ) - Hollywood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2021-10-21 |
| Est. Completion | 2022-02-26 |
| Phase | Phase 1 |
What the finished NCT05067439 record still lists
NCT05067439 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 65-participant average among 119 other Healthy Participants trials with a reported enrollment target (60% lower).
The record links to 1 condition, with Healthy Participants appearing as the primary indexed condition, and to 4 interventions - of which Abrocitinib is the first listed.
NCT05067439 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05067439 about?
NCT05067439 is a clinical study titled "A Study to Estimate the Effect of Multiple Dose Abrocitinib on Caffeine, Efavirenz, and Omeprazole in Healthy Participants". This is a Phase 1, open-label, multiple dose, single fixed-sequence, 2-period study to evaluate the effect of abrocitinib on the pharmacokinetics (PK) of caffeine, efavirenz and omeprazole in healthy adult participants. A total of approximately 13 healthy male and/or female participants will be enro...
What is the current status of trial NCT05067439?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2021-10-21. Estimated completion is 2022-02-26.
What conditions does trial NCT05067439 study?
This clinical trial studies the following conditions: Healthy Participants.
What interventions are being tested in trial NCT05067439?
The interventions under investigation include: Abrocitinib (DRUG), Omeprazole (DRUG), Caffeine (DRUG), Efavirenz (DRUG).
Who is sponsoring clinical trial NCT05067439?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05067439 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05067439's enrollment target sits among peer trials
26 77th of 119 higher than 42 of 119 other Healthy Participants trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Participants 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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