The purpose of this study is to understand how Osivelotor is processed in people with loss of liver function. This study is seeking participants that are: * stable loss of liver function with mild or moderate severity * none of underlying conditions possibly affecting the study medicine being absorbed by the body All participants will receive one amount of Osivelotor by mouth before breakfast on the first day at the study clinic. A number of blood samples will be collected to understand how Osivelotor is changed and removed from the body. Participants will also have to undergo physical examination and other tests. This will help to understand if Osivelotor is safe. Participants will take part in the study for a maximum of 112 days. During this time, participants will have to stay onsite for 5 days. There will be 5 study visits at the study clinic.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
8
a single dose of osivelotor administered by mouth under fasted conditions Other Names: PF-07940367
Orange County Research Center
Lake Forest, California, United States
Genesis Clinical Research, LLC
Tampa, Florida, United States
Thomas Jefferson University-Pharmacology, Physiology and Cancer Biology
Philadelphia, Pennsylvania, United States
Area under the whole blood and plasma concentration versus time curve (AUC) from time zero (pre-dose) to the last quantifiable concentration (AUClast) of osivelotor
Time frame: 0 hours (pre-dose) to 84 days post-osivelotor dose
Area under the whole blood and plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (AUCinf) of osivelotor
Time frame: 0 hours (pre-dose) to 84 days post-osivelotor dose
Maximum observed whole blood and plasma concentration (Cmax) of osivelotor
Time frame: 0 hours (pre-dose) to 84 days post-osivelotor dose
Number of Participants With Treatment-Emergent Adverse Events (AEs)
Time frame: From baseline up to 56 days after osivelotor dose
Number of Participants With Clinically Significant Laboratory Abnormalities
Time frame: From baseline up to 84 days after osivelotor dose
Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
Time frame: From baseline up to 84 days after osivelotor dose
Number of Participants With Clinically Significant With Clinically Significant Vital Signs
Time frame: From baseline up to 84 days after osivelotor dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.