Healthy Participants
Conditions
Keywords
Casdatifan, AB521, HIF-2α, Pharmacokinetics
Brief summary
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.
Interventions
DRUGCasdatifan
Administered as specified in the treatment arm
Sponsors
Arcus Biosciences, Inc.
Taiho Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 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. * Has adequate peripheral venous access.
Exclusion criteria
* 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). * Seizure (excluding simple febrile seizure), epilepsy, severe head injury, multiple sclerosis, or other known neurological conditions which the PI or designee considers to be clinically significant. NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed concentration for casdatifan | Up to 168 hours post each dose |
| Area under the concentration-time curve for casdatifan | Up to 168 hours post each dose |
Secondary
| Measure | Time frame |
|---|---|
| Time to reach Cmax (Tmax) for casdatifan | Up to 168 hours post each dose |
| Lag time (Tlag) for casdatifan | Up to 168 hours post each dose |
| Apparent first-order terminal elimination rate constant (Kel) for casdatifan | Up to 168 hours post each dose |
| Percent of AUC0-inf extrapolated for casdatifan | Up to 168 hours post each dose |
| Apparent first-order terminal elimination half-life (t½) for casdatifan | Up to 168 hours post each dose |
| Apparent total clearance after extravascular (oral) administration (CL/F) for casdatifan | Up to 168 hours post each dose |
| Apparent total clearance after extravascular (oral) administration (Vz/F) for casdatifan | Up to 168 hours post each dose |
| Number of participants experiencing Adverse Events (AEs) | Up to 43 days |
Countries
United States
Contacts
STUDY_DIRECTORMedical Director
Arcus Biosciences
Outcome results
None listed