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PF-06414300

Phase 1

Healthy Participants | Small molecule | Other |Pfizer, Inc.|Last Updated: Oct 1, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment63

FDA Designations

No designations recorded

Clinical trial landscape

PF-06414300 · 1 trial · 1 indication

Phase 1 1
NCT06659250A Study to Learn How Different Amounts and Forms of the Study Medicine Called PF-06414300 Act in Healthy AdultsHealthy Participants
COMPLETED63 Analytics
PHASE1COMPLETED
A Study to Learn How Different Amounts and Forms of the Study Medicine Called PF-06414300 Act in Healthy Adults
Healthy ParticipantsUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Adverse Events (AE) observed after single or multiple doses
Day 1 up to Day 28 (Part A)/Day 1 up to Day 38 (Part B)
Number of Serious AE observed after single or multiple doses
Day 1 up to Day 28 (Part A)/Day 1 up to Day 38 (Part B)
Number of participants with abnormal vital sign changes following single or multiple ascending doses
Day 1 up to Day 28 (Part A)/Day 1 up to Day 38 (Part B)
Number of Participants with Electrocardiogram (ECG) Abnormalities including QT and QTcF interval following single or multiple ascending dose
Day 1 up to Day 28 (Part A)/Day 1 up to Day 38 (Part B)
Number of participants with clinically significant laboratory values
Day 1 up to Day 28 (Part A)/Day 1 up to Day 38 (Part B)

Secondary Endpoints

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) Part A
Day 1 up to Day 4 (Part A)
Maximum Observed Plasma Concentration (Cmax) Part A
Day 1 up to Day 4 (Part A)
Time to Reach Maximum Observed Plasma Concentration (Tmax) Part A
Day 1 up to Day 4 (Part A)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
PF-06414300EXPERIMENTALParticipants will receive single or multiple ascending oral doses of PF-06414300
PlaceboPLACEBO_COMPARATORParticipants will receive matching placebo.

Interventions

NameTypeDescription
PF-06414300DRUGParticipants will receive oral ascending doses.
PlaceboDRUGParticipants will receive matching placebo.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Body mass Index (BMI) of 16-32 kg/m2; and a total body weight \>50 kg (110 lb). * Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs assessments, 12-lead ECGs a...

Countries:United States
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Frequently asked questions about PF-06414300

What is PF-06414300?

PF-06414300 is an investigational small molecule being developed by Pfizer, Inc. (PFE). It is currently in Phase 1 clinical development, studied in healthy participants. The drug is not approved and remains under investigation.

What is PF-06414300 used for?

PF-06414300 is being studied in healthy participants as part of early clinical research. Its intended therapeutic use has not been established, as it is still in Phase 1 development.

Who makes PF-06414300?

PF-06414300 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker PFE.

What phase is PF-06414300 in?

PF-06414300 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities.

What clinical trials is PF-06414300 in?

PF-06414300 has one completed Phase 1 trial, NCT06659250, which studied how different amounts and forms of the drug act in healthy adults. The trial enrolled 63 participants in the United States.

Is PF-06414300 FDA approved?

No, PF-06414300 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development, and its safety and efficacy have not been established.