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

NCT06919991 | Completed Phase 1 FDA Drug

• 1 other identifier: ARC-29
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Keywords

AB521; Casdatifan; HIF-2α; hypoxia-inducible factor 2 alpha

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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

Study Arms (1)

Casdatifan-Itraconazole-Phenytoin

EXPERIMENTAL

Participants will receive casdatifan, itraconazole, and phenytoin.

Drug: Casdatifan; Drug: Itraconazole; Drug: Phenytoin

Interventions

Casdatifan DRUG

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

Casdatifan-Itraconazole-Phenytoin

Itraconazole DRUG

Administered as multiple doses in treatment Period 2

Casdatifan-Itraconazole-Phenytoin

Phenytoin DRUG

Administered as multiple doses in treatment Period 3

Casdatifan-Itraconazole-Phenytoin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arcus Biosciences, Inc.: lead

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Interventions

Itraconazole; Phenytoin

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Hydantoins; Imidazolidines; Imidazoles

Study Officials

• Medical Director

  Arcus Biosciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 9, 2025
• Study Start: May 2, 2025
• Primary Completion: October 18, 2025
• Study Completion: October 18, 2025
• Last Updated: November 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

US (1)