Healthy Participants
Conditions
Keywords
AB521, Casdatifan, HIF-2α, hypoxia-inducible factor 2 alpha
Brief summary
The purpose of the study is to assess the effects of multiple doses of itraconazole (a strong CYP3A4 inhibitor) on single dose PK of casdatifan in healthy adults and to assess the effects of multiple doses of phenytoin (a strong CYP3A4 inducer) on single dose PK of casdatifan in healthy adults.
Interventions
DRUGCasdatifan
Administered as a single dose in treatment Periods 1, 2, and 3
DRUGItraconazole
Administered as multiple doses in treatment Period 2
DRUGPhenytoin
Administered as multiple doses in treatment Period 3
Sponsors
Arcus Biosciences, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy, adult, male or female 18-55 years of age, inclusive, at the screening visit. * Male participants must be vasectomized * 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 * Able to swallow multiple tablets and/or capsules.
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 or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee. * 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 or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds. * History of asthma or chronic obstructive pulmonary disease (including childhood), clinically significant food allergies or anaphylaxis, as deemed by PI or designee. NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under the Plasma Drug Concentration-Time Curve (AUC) for casdatifan | Up to 168 hours post dose for Period 1; up to 216 hours post dose for Period 2; and up to 120 hours post dose for Period 3 |
| Maximum Concentration (Cmax) in Plasma for casdatifan | Up to 168 hours post dose for Period 1; up to 216 hours post dose for Period 2; and up to 120 hours post dose for Period 3 |
| Time to Maximum Concentration (Tmax) in Plasma for casdatifan | Up to 168 hours post dose for Period 1; up to 216 hours post dose for Period 2; and up to 120 hours post dose for Period 3 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with Treatment Emergent Adverse Events (TEAEs) | Up to 26.2 weeks |
| Concentration observed at the end of the dosing interval (Ctrough) for itraconazole (Period 2) and phenytoin (Period 3) | Up to 18 days |
Countries
United States
Outcome results
None listed