The purpose of this study is to compare the single-dose pharmacokinetics (PK) of casdatifan 100 mg versus four 25 mg tablets under fasting conditions in healthy adult participants, and to evaluate the effect of food on the single-dose PK of casdatifan 100 mg administered as four 25 mg tablets in healthy adult participants.
Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on participant self-reporting.
BMI ≥ 18.0 and ≤ 32.0 kg/m2 and body weight ≥ 45 kg at the screening visit.
Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, standard vital signs, and ECGs, as deemed by the PI or designee.
Able to swallow multiple tablets.
Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
History 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.
History of asthma or chronic obstructive pulmonary disease (including childhood), clinically significant food allergies or anaphylaxis, as deemed by PI or designee.
Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of asymptomatic gallstones).
Crossover
Casdatifan
DrugAdministered as specified in the treatment arm
Maximum observed concentration for casdatifan
Area under the concentration-time curve for casdatifan
Time to reach Cmax (Tmax) for casdatifan
Lag time (Tlag) for casdatifan
Apparent first-order terminal elimination rate constant (Kel) for casdatifan
Percent of AUC0-inf extrapolated for casdatifan
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Arcus Biosciences, Inc.
Lead sponsor
Taiho Pharmaceutical Co., Ltd.
Collaborator
