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NCT05431153 · ClinicalTrials.gov registry record · Phase 1
A Study to Investigate the Effect of Tablet Formulation and Food on PF-07104091 in Healthy Participants
A Phase 1 study of Healthy, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT05431153: Completed Phase 1 study of Healthy, sponsored by Pfizer.
NCT05431153 is a Phase 1 study of Healthy that has completed, run by Pfizer. The registered enrollment target is 30 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05431153, a Phase 1 study of Healthy, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single dose crossover pharmacokinetic (pharmacokinetics helps in understanding how the drug is changed and eliminated from the body after a participant takes it) study in healthy participants. The study consists of 5 treatments, and each participant will be randomized to receive 4 of the treatments in separate periods in a specific sequence. Each treatment consists of a single dose of PF-07104091 and the treatments differ by tablet formulation and/or whether the dose is to be given under fasted or fed conditions. Plasma pharmacokinetics of PF-07104091 will be assessed following each dose to determine the effect of tablet formulation and fed condition on the relative bioavailability of PF-07104091.
Primary Outcome
AUCinf was calculated as AUClast + (Clast/kel) where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve.
Conditions Studied
Interventions
- DRUG Single dose of PF-07104091 as Tablet Formulation A (Treatment A)
- DRUG Single dose of PF-07104091 as Tablet Formulation B (Treatment B)
- DRUG Single dose of PF-07104091 as Tablet Formulation C (Treatment C)
- DRUG Single dose of PF-07104091 as Tablet Formulation D (Treatment D)
- DRUG Single dose of PF-07104091 as Tablet Formulation C (Treatment E)
Study Locations (1)
Connecticut
- New Haven Clinical Research Unit - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2022-06-10 |
| Est. Completion | 2022-10-17 |
| Phase | Phase 1 |
What the finished NCT05431153 record still lists
NCT05431153 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 5 interventions - of which Single dose of PF-07104091 as Tablet Formulation A (Treatment A) is the first listed.
NCT05431153 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT05431153 about?
NCT05431153 is a clinical study titled "A Study to Investigate the Effect of Tablet Formulation and Food on PF-07104091 in Healthy Participants". This is a single dose crossover pharmacokinetic (pharmacokinetics helps in understanding how the drug is changed and eliminated from the body after a participant takes it) study in healthy participants. The study consists of 5 treatments, and each participant will be randomized to receive 4 of the t...
What is the current status of trial NCT05431153?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2022-06-10. Estimated completion is 2022-10-17.
What conditions does trial NCT05431153 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT05431153?
The interventions under investigation include: Single dose of PF-07104091 as Tablet Formulation A (Treatment A) (DRUG), Single dose of PF-07104091 as Tablet Formulation B (Treatment B) (DRUG), Single dose of PF-07104091 as Tablet Formulation C (Treatment C) (DRUG), Single dose of PF-07104091 as Tablet Formulation D (Treatment D) (DRUG), Single dose of PF-07104091 as Tablet Formulation C (Treatment E) (DRUG).
Who is sponsoring clinical trial NCT05431153?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05431153 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05431153's enrollment target sits among peer trials
30 678th of 1090 higher than 363 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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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