Status:
COMPLETED
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PF-06842874 in Healthy Participants
Lead Sponsor:
Pfizer
Conditions:
Healthy Participants
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study will be the first time PF-06842874 is administered to humans. The purpose of Part A of the study is to investigate the safety, tolerability, and pharmacokinetics of PF-06842874 following ad...
Eligibility Criteria
Inclusion
- 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; and a total body weight \>50 kg (110 lb).
- Capable of giving signed informed consent.
Exclusion
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
- Any condition possibly affecting drug absorption.
- History of human immunodeficiency virus infection (HIV), hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody.
- Participants with benign ethnic neutropenia or cyclic neutropenia.
- Other acute or chronic medical or psychiatric condition.
- Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product.
- Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of investigational product used in this study (whichever is longer).
- A positive urine drug test.
- Screening supine blood pressure (BP) ≥140 mmHg (systolic) or ≥90 mmHg (diastolic), following at least 5 minutes of supine rest.
- Baseline 12-lead standard electrocardiogram (ECG) that demonstrates clinically relevant abnormalities.
- Participants with ANY of the following abnormalities in clinical laboratory tests at screening: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≥1.25× upper limit of normal (ULN); total bilirubin level ≥1.5× ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ULN; hemoglobin ≤14 gm/dL (males) and ≤13 gm/dL (females); neutrophils \<1500 cells/mm3.
- History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of screening.
- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or Pfizer employees, including their family members, directly involved in the conduct of the study.
Key Trial Info
Start Date :
October 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 26 2021
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04124653
Start Date
October 17 2019
End Date
July 26 2021
Last Update
December 6 2021
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
New Haven Clinical Research Unit
New Haven, Connecticut, United States, 06511
2
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, United States, 06511