Healthy Participants, Hepatic Impairment
Conditions
Keywords
Casdatifan, AB521, HIF-2α, Pharmacokinetics, Hepatic Impairment
Brief summary
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.
Interventions
DRUGCasdatifan
Participants will receive a 100 mg single oral dose of casdatifan.
Sponsors
Arcus Biosciences, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 84 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration time curve, from time 0 to the last observed non-zero concentration, of casdatifan in plasma (AUC0-t) | Up to 10 days post-dose |
| Area under the concentration time curve from time 0 extrapolated to infinity of casdatifan in plasma (AUC0-inf) | Up to 10 days post-dose |
| Maximum observed concentration of casdatifan in plasma (Cmax) | Up to 10 days post-dose |
Secondary
| Measure | Time frame |
|---|---|
| Time to reach Cmax of casdatifan in plasma (Tmax) | Up to 10 days post-dose |
| Apparent first order terminal elimination rate constant calculated from a semi log plot of the plasma concentration versus time curve (Kel) | Up to 10 days post-dose |
| Percent of AUC0-inf extrapolated (AUC%extrap) | Up to 10 days post-dose |
| Apparent first order terminal elimination half life (t½) | Up to 10 days post-dose |
| Apparent total clearance (CL/F) | Up to 10 days post-dose |
| Apparent total clearance (Vz/F) | Up to 10 days post-dose |
| Unbound fraction (fu) of casdatifan | Up to 10 days post-dose |
| Number of participants experiencing Adverse Events (AEs) | Up to 23 days post-dose |
Countries
United States
Contacts
CONTACTMedical Director
STUDY_DIRECTORMedical Director
Arcus Biosciences
Outcome results
None listed