Status:
COMPLETED
Drug-Drug Interaction Study of Casdatifan in Healthy Adult Participants (ARC-29)
Lead Sponsor:
Arcus Biosciences, Inc.
Conditions:
Healthy Participants
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 18 2025
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT06919991
Start Date
May 2 2025
End Date
October 18 2025
Last Update
November 13 2025
Active Locations (1)
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1
Celerion
Tempe, Arizona, United States, 85283