Overview
The purpose of the study is to compare the single dose PK of casdatifan between participants with moderate hepatic impairment (HI) and healthy matched control participants with normal hepatic function.
Eligibility
Inclusion Criteria:
All Participants:
- Male participants must be vasectomized
- BMI ≥ 18.0 and ≤ 42.0 kg/m2 and body weight ≥ 45 kg at screening.
Participants with Moderate HI (Group 1)
- Is classified as having moderate HI by the Child-Pugh classification system (Class B, score of 7 to 9, inclusive) at screening.
- Has a diagnosis of chronic (\> 6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) hepatic insufficiency at screening
Healthy Participants:
- Healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and ECGs, as deemed by the PI or designee
Exclusion Criteria:
All Participants:
- Participants with Gilbert's syndrome.
Participants with Moderate HI (Group 1):
- Positive for HBsAg or HCV Ab, and detectable viral load at screening.
- Severe complications of liver disease within the preceding 3 months of screening.
- Fluctuating or rapidly deteriorating hepatic function from screening until prior to dosing, in the opinion of the PI or designee.
Healthy Control Participants:
- History or presence of clinically significant medical or psychiatric condition or disease, or presence of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
