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PF-06842874

Phase 1

Undisclosed | Small molecule | Other |Pfizer, Inc.|Trials Updated: Dec 6, 2021

PF-06842874 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Oct 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment44

FDA Designations

No designations recorded

PF-06842874 clinical trials

PF-06842874 · 1 trial · 1 indication

Phase 1 1
NCT04124653A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PF-06842874 in Healthy ParticipantsHealthy Participants
COMPLETED44 Analytics
PHASE1COMPLETED
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PF-06842874 in Healthy Participants
Healthy ParticipantsUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Baseline up to 35 days after last dose of study medication

Treatment-related AEs are any untoward medical occurrences attributed to study drug in a participant who received study drug.

Number of Participants With Clinical Laboratory Abnormalities
Baseline up to 10 days after last dose of study medication

The following parameters will be analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, lactate dehydrogenase, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, phosphate, bicarbonate); clinical chemistry (glucose, creatine kinase); immunology (CRP); urinalysis (dipstick \[urine specific gravity, decimal logarithm of reciprocal of hydrogen ion activity {pH} of urine, glucose, protein, blood, ketones, bilirubin\], microscopy \[urine RBC, WBC, urate crystals, calcium, oxalate, miscellaneous \[urine mucus and leucocytes\]).

Number of Participants With Clinically Significant Change From Baseline in Vital Signs
0, 1, 2, 3, 5, 8, 12, 24, and 48 hours post-dose

The following parameters will be analyzed for examination of vital signs: systolic blood pressure, diastolic blood pressure, and pulse rate.

Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings
0, 1, 2, 3, 5, 8, 12, 24, and 48 hours post-dose

Measurements of heart rate, PR interval, QT interval, QTc intervals, and QRS complex

Abnormal rhythms as observed continuous cardiac monitoring
0 to 8 hours post-dose

Cardiac rhythms measured by continuous cardiac telemetry

Number of Participants With Clinically-Significant Change From Baseline in Physical Examination Findings
Baseline up to 10 days after last dose of study medication

A complete physical examination includes, at a minimum, head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, and gastrointestinal, musculoskeletal, and neurological systems. A limited physical examination includes, at a minimum, assessments of general appearance, the respiratory and cardiovascular systems, and participant-reported symptoms.

Secondary Endpoints

Maximum Observed Plasma Concentration (Cmax) of PF-06842874
0, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, and 48 hours post-dose
Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) of PF-06842874
0, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, and 48 hours post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-06842874
0, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, and 48 hours post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
PF-06842874/PlaceboEXPERIMENTALSingle dose administration of PF-06842874 or placebo
Relative BioavailabilityEXPERIMENTALDetermination of relative bioavailability of modified-release formulation relative to immediate-release formulation

Interventions

NameTypeDescription
PF-06842874DRUGSingle dose administration of PF-06842874
PlaceboDRUGSingle dose administration of placebo
Relative BioavailabilityDRUGRelative bioavailability assessment of modified-release formulation
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Female participants of non-childbearing potential and male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, clinical laboratory tests, and cardiac monitoring. * Body mass index (BMI) of 17.5 to 30.5 kg/m2...

Countries:United States
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Frequently asked questions about PF-06842874

What is PF-06842874?

PF-06842874 is an investigational small molecule developed by Pfizer, Inc. (ticker PFE). It has been studied in a Phase 1 clinical trial in healthy adult participants. The specific disease or condition it is intended to treat has not been disclosed.

Who makes PF-06842874?

PF-06842874 is being developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer sponsored the Phase 1 study of the compound in healthy participants. No partnership or licensing arrangement for this asset has been announced.

What phase is PF-06842874 in?

PF-06842874 is in Phase 1 development. Its only recorded clinical trial, NCT04124653, was a Phase 1 study that has been completed. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is PF-06842874 in?

PF-06842874 has been evaluated in one clinical trial, NCT04124653, titled a study to evaluate the safety, tolerability, and pharmacokinetics of PF-06842874 in healthy participants. The Phase 1 trial enrolled 44 participants in the United States and is completed, with no active trials ongoing.

What did the PF-06842874 Phase 1 trial study?

The Phase 1 trial NCT04124653 evaluated the safety, tolerability, and pharmacokinetics of PF-06842874 in healthy participants. It was a randomized, double-blind, controlled study that enrolled 44 adults aged 18 years and older in the United States. The trial is completed.