Drug-Drug Interaction Study of Casdatifan in Healthy Adult Participants (ARC-29)

Phase 1

Recruiting

• Conditions: Healthy Participants
• Interventions: Drug: Casdatifan; Drug: Itraconazole; Drug: Phenytoin

• Registration Number: NCT06919991
• Lead Sponsor: Arcus Biosciences, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-27
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-02
• Study First Posted: 2025-04-09
• Study Start: 2025-05-02
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-18
• Primary Completion: 2025-08
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Casdatifan-Itraconazole-Phenytoin	Casdatifan	Participants will receive casdatifan, itraconazole, and phenytoin.
Casdatifan-Itraconazole-Phenytoin	Itraconazole	Participants will receive casdatifan, itraconazole, and phenytoin.
Casdatifan-Itraconazole-Phenytoin	Phenytoin	Participants will receive casdatifan, itraconazole, and phenytoin.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Celerion; 🇺🇸 Tempe, Arizona, United States