Clinical trial NCT06919991: Drug-Drug Interaction Study of Casdatifan in Healthy Adult Participants (ARC-29)
Official title: A Phase 1, Open-Label, Fixed-Sequence, Drug-Drug Interaction Study of Casdatifan With Itraconazole (Strong CYP3A4 Inhibitor) and Phenytoin (Strong CYP3A4 Inducer) in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Participants
Keywords: AB521
Casdatifan
HIF-2α
hypoxia-inducible factor 2 alpha
Lead sponsor: Arcus Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2025-04-09
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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/Exclusion criteria may apply.

Primary outcomes:
measure: Area Under the Plasma Drug Concentration-Time Curve (AUC) for casdatifan
timeFrame: 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
measure: Maximum Concentration (Cmax) in Plasma for casdatifan
timeFrame: 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
measure: Time to Maximum Concentration (Tmax) in Plasma for casdatifan
timeFrame: 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 outcomes:
measure: Number of Participants with Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to 26.2 weeks
measure: Concentration observed at the end of the dosing interval (Ctrough) for itraconazole (Period 2) and phenytoin (Period 3)
timeFrame: Up to 18 days
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion
state: Arizona
Study officials:
affiliation: Arcus Biosciences
name: Medical Director
role: STUDY_DIRECTOR
References: