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PF-06852231

Phase 1

Healthy Volunteers | Small molecule | Other |Pfizer, Inc.|Last Updated: Feb 14, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment17

FDA Designations

No designations recorded

Clinical trial landscape

PF-06852231 · 1 trial · 1 indication

Phase 1 1
NCT03217604A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Doses of PF-06852231 in Healthy SubjectsHealthy Volunteers
COMPLETED17 Analytics
PHASE1COMPLETED
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Doses of PF-06852231 in Healthy Subjects
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Baseline up to 14 days after last dose of study medication

Treatment-related AE are any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to Y days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to study drug is assessed either yes or no by the investigator. Participants with multiple occurrences of an AE within a category are counted once within the category.

Number of Participants With Laboratory Abnormalities
Baseline up to 14 days after last dose of study medication

Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid albumin, total protein); urinalysis (decimal logarithm of reciprocal of hydrogen ion activity \[pH\], glucose, protein, blood, ketones, microscopy\[if urine tested positive for blood or protein\]).

Number of Participants With Clinically Significant Change From Baseline in Vital Signs
0, 1, 2, 4, 8, 12, 24, 48, 72 hours(h) post-dose

Following parameters were analyzed for examination of vital signs: systolic and diastolic blood pressure, pulse rate, and body temperature.

Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings
0, 1, 2, 4, 8, 12, 24, 48, 72 h post-dose

Absolute values and changes from baseline for ECG parameters

Abnormal rhythms as observed continuous cardiac telemetry
8 h post-dose

Cardiac rhythms measured by continuous cardiac monitoring

Secondary Endpoints

Maximum Observed Plasma Concentration (Cmax) for PF-06852231
0, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 h post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06852231
0, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 h post-dose
Area Under the Curve From Time Zero to Time of Last Measurable Plasma Concentration (AUClast) for PF-06852231
0, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 h post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORPlacebo
PF-06852231EXPERIMENTALSingle ascending doses of PF-06852231

Interventions

NameTypeDescription
PlaceboDRUGTreatment with placebo
PF-06852231DRUGTreatment with PF-06852231
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy female subjects of non-childbearing potential and male subjects, who at the time of screening are between ages of 18 and 55 years inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination,...

Countries:Belgium
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Frequently asked questions about PF-06852231

What is PF-06852231?

PF-06852231 is an investigational small molecule being developed by Pfizer, Inc. It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers to evaluate its safety, tolerability, and pharmacokinetics. It is not approved and remains in clinical development.

What is PF-06852231 used for?

PF-06852231 is being studied for use in healthy volunteers. The completed Phase 1 trial assessed the safety, tolerability, and pharmacokinetics of single doses of the drug. Its intended therapeutic use has not been established, as it is still in early clinical development.

Who makes PF-06852231?

PF-06852231 is being developed by Pfizer, Inc., which is publicly traded under the ticker symbol PFE. The company conducted a Phase 1 clinical trial of the drug in healthy volunteers.

What phase is PF-06852231 in?

PF-06852231 is in Phase 1 clinical development. One Phase 1 trial has been completed, and the drug remains investigational. It has not been approved by regulatory authorities and is still undergoing clinical evaluation.

What clinical trials is PF-06852231 in?

PF-06852231 has one completed clinical trial, NCT03217604, titled "A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Doses of PF-06852231 in Healthy Subjects." This Phase 1 trial enrolled 17 participants in Belgium and was placebo-controlled and double-blinded.