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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 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.

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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.

Conditions Studied

Healthy

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

FieldValue
Enrollment Target 30 participants
Start Date 2022-06-10
Est. Completion 2022-10-17
Phase Phase 1

Sponsor

Pfizer

1,845 total trials

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What the Registry Record Tells You About NCT05431153

The ClinicalTrials.gov registry entry for NCT05431153 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower). The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.