Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-06852231 · 1 trial · 1 indication
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.
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\[if urine tested positive for blood or protein\]).
Following parameters were analyzed for examination of vital signs: systolic and diastolic blood pressure, pulse rate, and body temperature.
Absolute values and changes from baseline for ECG parameters
Cardiac rhythms measured by continuous cardiac monitoring
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo |
| PF-06852231 | EXPERIMENTAL | Single ascending doses of PF-06852231 |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Treatment with placebo |
| PF-06852231 | DRUG | Treatment with PF-06852231 |
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,...
PF-06852231 is an investigational small molecule developed by Pfizer, Inc. It has been studied in a Phase 1 clinical trial in healthy adult volunteers. The specific disease or condition it is intended to treat has not been disclosed.
PF-06852231 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker symbol PFE. Pfizer sponsored the Phase 1 study of the compound conducted in Belgium.
PF-06852231 is in Phase 1 clinical development. The only reported trial was a Phase 1 study that has been completed. It is an investigational agent and is not approved by the FDA for any indication.
PF-06852231 has been evaluated in one clinical trial, NCT03217604, titled A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Doses of PF-06852231 in Healthy Subjects. The Phase 1 trial enrolled 17 healthy volunteers in Belgium and is completed.
The Phase 1 trial NCT03217604 was a randomized, double-blind, placebo-controlled study of single doses of PF-06852231 in healthy subjects. It enrolled 17 participants aged 18 years and older in Belgium and has been completed.