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Completed

NCT Number: NCT06919991

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Tempe, Arizona, 85283, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

casdatifan

Drug

Administered as a single dose in treatment Periods 1, 2, and 3

Itraconazole

Drug

Administered as multiple doses in treatment Period 2

Phenytoin

Drug

Administered as multiple doses in treatment Period 3

Primary outcomes

  1. Area Under the Plasma Drug Concentration-Time Curve (AUC) for casdatifan

    Time frame: 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

  2. Maximum Concentration (Cmax) in Plasma for casdatifan

    Time frame: 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

  3. Time to Maximum Concentration (Tmax) in Plasma for casdatifan

    Time frame: 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

  1. Number of Participants with Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to 26.2 weeks

  2. Concentration observed at the end of the dosing interval (Ctrough) for itraconazole (Period 2) and phenytoin (Period 3)

    Time frame: Up to 18 days

Sponsors and collaborators

Lead sponsor

Arcus Biosciences, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 9, 2025
Registry last updated
Nov 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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