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PF-06842874

Phase 1

Healthy Participants | Small molecule | Other |Pfizer, Inc.|Last Updated: Dec 6, 2021

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

Clinical trial landscape

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 being developed by Pfizer, Inc. (PFE). It is currently in Phase 1 clinical development for use in healthy participants. The drug is being studied to evaluate its safety, tolerability, and pharmacokinetics.

What is PF-06842874 used for?

PF-06842874 is being studied for use in healthy participants. The purpose of the clinical trial is to evaluate the safety, tolerability, and pharmacokinetics of the drug. It is an investigational small molecule and is not yet approved for any medical condition.

Who makes PF-06842874?

PF-06842874 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical development.

What phase is PF-06842874 in?

PF-06842874 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing.

What clinical trials is PF-06842874 in?

PF-06842874 has one completed clinical trial, identified as NCT04124653. This Phase 1 study evaluated the safety, tolerability, and pharmacokinetics of the drug in 44 healthy participants in the United States. The trial was randomized, double-blind, and controlled.

Is PF-06842874 FDA approved?

PF-06842874 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial, NCT04124653, was designed to evaluate safety, tolerability, and pharmacokinetics in healthy participants, but the drug has not been approved for any use.