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NCT04065633 · ClinicalTrials.gov registry record · Phase 1
Study of Commercial and Phase 3 of PF-04965842 Formulations, Estimation of Effect of Food on Commercial Formulation
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
NCT04065633 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 46 participants.
The verdict
NCT04065633, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
Study Summary
Part A * To measure and compare the amount of study drug in the blood after a single 200 mg dose of study drug given as the commercial tablet formulation and the Phase 3 tablet formulation under fasting conditions * To measure and compare the amount of study drug in the blood after a single 200 mg dose given as the variant Phase 3 tablet formulation and the Phase 3 tablet formulation under fasting conditions * To estimate the effect of food on the amount of study drug in the blood after a single 200 mg dose of the commercial formulation Part B • To measure and compare the amount of study drug in the blood after a single 200 mg dose given as the commercial tablet formulation and the Phase 3 tablet formulation under fasting conditions Parts A \& B * To collect samples for genotyping (CYP2C19 and CYP2C9 - enzymes that metabolize \[break down\] certain medications) o Genotyping is the collection of a small sample of blood that contains your genes * To evaluate the safety and tolerability of the study drug after single 200 mg doses of the three different formulations given to healthy participants * To measure the amount of study drug in the blood after single doses of the different formulations * To collect exploratory samples for biobanking o Biobanking is the collection and storage of blood samples for possible future testing
Interventions
- DRUG P3-Fast
- DRUG Comm-Fast
- DRUG Vari-Fast
- DRUG Comm-Fed
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2019-07-18 |
| Est. Completion | 2019-12-14 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04065633
The ClinicalTrials.gov registry entry for NCT04065633 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 46 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 4 interventions - of which P3-Fast is the first listed.
NCT04065633 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04065633 about?
NCT04065633 is a clinical study titled "Study of Commercial and Phase 3 of PF-04965842 Formulations, Estimation of Effect of Food on Commercial Formulation". Part A * To measure and compare the amount of study drug in the blood after a single 200 mg dose of study drug given as the commercial tablet formulation and the Phase 3 tablet formulation under fasting conditions * To measure and compare the amount of study drug in the blood after a single 200 mg ...
What is the current status of trial NCT04065633?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2019-07-18. Estimated completion is 2019-12-14.
What interventions are being tested in trial NCT04065633?
The interventions under investigation include: P3-Fast (DRUG), Comm-Fast (DRUG), Vari-Fast (DRUG), Comm-Fed (DRUG).
Who is sponsoring clinical trial NCT04065633?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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