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PF-06954522 IR

Phase 1

Healthy Participants | Small molecule | Other |Pfizer, Inc.|Last Updated: Oct 8, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment23

FDA Designations

No designations recorded

Clinical trial landscape

PF-06954522 IR · 1 trial · 1 indication

Phase 1 1
NCT06393517A Study to Learn How Different Forms of the Study Medicine Called PF-06954522 Are Taken up Into the Blood in Healthy AdultsHealthy Participants
COMPLETED23 Analytics
PHASE1COMPLETED
A Study to Learn How Different Forms of the Study Medicine Called PF-06954522 Are Taken up Into the Blood in Healthy Adults
Healthy ParticipantsUnlock trial analytics

Study Endpoints

Primary Endpoints

Area Under the Curve from time zero to extrapolated infinite time (AUCinf) of PF-06954522 to evaluate the relative bioavailability of three PF-06954522 formulations administered in the fasted state.
0 hours (pre-dose) to 72 hours (extrapolated to infinite time) post PF-06954522 dose in each period
Maximum Observed Plasma Concentration (Cmax) of PF-06954522 to evaluate the relative bioavailability of three PF-06954522 formulations administered in the fasted state.
0 hours (pre-dose) to 72 hours post PF-06954522 dose in each period

Secondary Endpoints

Number of Participants with Treatment-Emergent Adverse Events (AEs)
From baseline up to 49 days after PF-06954522 dose in Period 1 Day 1
Number of Participants with Laboratory Test Abnormalities
From baseline up to 72 hours after PF-06954522 dose in each period
Number of Participants with Summary of Post-Baseline Vital Signs Data
From baseline up to 72 hours after PF-06954522 dose in each period
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Sequence 1EXPERIMENTALParticipants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as: Formulation 1 , Formulation 2, and Formulation 3 under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 2 and 3 under fed conditions in Periods 4 and 5, respectively.
Sequence 2EXPERIMENTALParticipants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as: Formulation 2, Formulation 3, and Formulation 1 under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 2 and 3 under fed conditions in Periods 4 and 5, respectively.
Sequence 3EXPERIMENTALParticipants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as: Formulation 3, Formulation 1, and Formulation 2, under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 2 and 3 under fed conditions in Periods 4 and 5, respectively.
Sequence 4EXPERIMENTALParticipants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as: Formulation 3, Formulation 2, and Formulation 1 under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 3 and 2 under fed conditions in Periods 4 and 5, respectively.
Sequence 5EXPERIMENTALParticipants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as: Formulation 1, Formulation 3, and Formulation 2 under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 3 and 2 under fed conditions in Periods 4 and 5, respectively.
Sequence 6EXPERIMENTALParticipants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as: Formulation 2, Formulation 1, and Formulation 3 under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 3 and 2 under fed conditions in Periods 4 and 5, respectively.

Interventions

NameTypeDescription
PF-06954522 IR (Formulation 1)DRUGParticipants to receive a single dose (Dose Level 1 and 2) of PF-06954522 Formulation 1 by mouth
PF-06954522 MR (Formulation 2)DRUGParticipants to receive a single dose (Dose Level 1 and 2) of PF-06954522 Formulation 2 by mouth.
PF-06954522 MR (Formulation 3)DRUGParticipants to receive a single dose (Dose Level 1 and 2) of PF-06954522 Formulation 3 by mouth
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Male and female participants of non-childbearing potential aged 18 years or older who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and electrocardiograms. * Body mass index of 16-32 kg/m...

Countries:United States
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Frequently asked questions about PF-06954522 IR

What is PF-06954522 IR?

PF-06954522 IR is an investigational small molecule being developed by Pfizer, Inc. (PFE). It is currently in Phase 1 clinical development. The drug is being studied in healthy participants to evaluate how different forms of the study medicine are taken up into the blood.

What is PF-06954522 IR used for?

PF-06954522 IR is being studied in healthy participants as part of a Phase 1 clinical trial. The study aims to learn how different forms of the study medicine are taken up into the blood. It is not yet approved for any medical condition and remains in clinical development.

Who makes PF-06954522 IR?

PF-06954522 IR is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical development.

What phase is PF-06954522 IR in?

PF-06954522 IR is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, with results not yet reported.

What clinical trials is PF-06954522 IR in?

PF-06954522 IR has one completed Phase 1 clinical trial, identified as NCT06393517. The study, titled "A Study to Learn How Different Forms of the Study Medicine Called PF-06954522 Are Taken up Into the Blood in Healthy Adults," enrolled 23 participants in the United States.