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NCT05767905 · ClinicalTrials.gov registry record · Phase 1
A Study to Understand the Effect of Tablet Formulation and Food on PF-06821497 in Healthy Adult Participants.
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT05767905: Completed Phase 1 study, sponsored by Pfizer.
NCT05767905 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05767905, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
The purpose of this study is to understand the effect of tablet formulation and presence of food on the study medicine PF-06821497 in healthy adult participants. The study is seeking for male and female participants who: * Are 18 years of age or more. * Are confirmed to be healthy after performing some medical and physical tests. * Weigh more than 50kgs of body weight and have a body mass index of 17 and a half kg per meter squared or more. The study consists of two parts. In each part of the study, the selected participants will take part in 3 study periods to receive 3 different treatments which are randomly assigned. There will also be a 5-day gap between each study period. This is done so that the medicine is passed out of the body before the start of next study period. Each treatment consists of a single dose of PF-06821497. The treatments differ by tablet formulation and/or whether the medicine is to be given with food or without food conditions. How the medicine is processed in the body will be studied after giving the medicines to the participants. This will be done by collecting blood samples after each administration. The results will be used to see the effect of tablet formulation and presence of food on the amount of PF-06821497 available in the blood of the participants. In each part, participants will be on the study up to 10 weeks, including the screening and follow-up periods.
Primary Outcome
The AUCinf was determined by AUClast + (Clast/kel), where Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve. AUClast is the area under the concentration-time curve from 0 to time of last measurable concentration
Interventions
- DRUG PF-06821497 Treatment A
- DRUG PF-06821497 Treatment B
- DRUG PF-06821497 Treatment C
- DRUG PF-06821497 Treatment D
- DRUG PF-06821497 Treatment E
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2023-03-17 |
| Est. Completion | 2023-06-20 |
| Phase | Phase 1 |
What the finished NCT05767905 record still lists
NCT05767905 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 5 interventions - of which PF-06821497 Treatment A is the first listed.
NCT05767905 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05767905 about?
NCT05767905 is a clinical study titled "A Study to Understand the Effect of Tablet Formulation and Food on PF-06821497 in Healthy Adult Participants.". The purpose of this study is to understand the effect of tablet formulation and presence of food on the study medicine PF-06821497 in healthy adult participants. The study is seeking for male and female participants who: * Are 18 years of age or more. * Are confirmed to be healthy after performing...
What is the current status of trial NCT05767905?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2023-03-17. Estimated completion is 2023-06-20.
What interventions are being tested in trial NCT05767905?
The interventions under investigation include: PF-06821497 Treatment A (DRUG), PF-06821497 Treatment B (DRUG), PF-06821497 Treatment C (DRUG), PF-06821497 Treatment D (DRUG), PF-06821497 Treatment E (DRUG).
Who is sponsoring clinical trial NCT05767905?
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 NCT05767905's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 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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