A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED EVALUATION OF SINGLE DOSES OF PF-07209326 IN HEALTHY PARTICIPANTS (SAFETY, TOLERABILITY, AND PHARMACOKINETICS PK) FOLLOWED BY AN OPENLABEL, REPEAT DOSE EVALUATION IN SICKLE CELL DISEASE PARTICIPANTS (SAFETY, TOLERABILITY, PK AND EFFICACY)
Study of PF-07209326 in Patients with Sickle Cell Disease
Sponsor: Pfizer
Enrolling: Male and Female Patients
Study Length: 5 Months
Clinic Visits: 10
IRB Number: AAAT9782
U.S. Govt. ID: NCT04255875
Contact: Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu
Additional Study Information: The purpose of this study is to learn about whether the study drug (PF-07209326) is safe and effective in people with sickle cell disease and learn about what the right dose is. We will look at drug levels in the blood, see how fast drug levels rise and fall, and what effects the drug has, all of which are known as the pharmacokinetics (PK) and pharmacodynamics (PD) of a drug. In addition, this study will learn if this drug is able to prevent the painful episodes (vaso-occlusive crises) that occur. The study drug (PF-07209326) is an investigational drug because it is not approved for use in this country.
This study is closed
Investigator
Andrew Eisenberger, MD
Do You Qualify?
Are you between the ages of 18-65? Yes No
Have you been diagnosed with sickle cell disease? Yes No
Are you willing to spend 5 minutes every day completing a eDiary about your sickle cell pain for 3 months? Yes No
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For more information, please contact:
Research Nurse Navigator
cancerclinicaltrials@cumc.columbia.edu
212-342-5162