COMPLETED

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

Conditions

Healthy Participants AB521 Casdatifan HIF-2α hypoxia-inducible factor 2 alpha

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-05-02

Study Completion:2025-10-18

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06919991

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Principal Investigator

Medical Director

STUDY_DIRECTOR

Arcus Biosciences

Study Locations (Sites)

Celerion

Tempe, Arizona, 85283

United States

Collaborators and Investigators

Sponsor: Arcus Biosciences, Inc.

Medical Director, STUDY_DIRECTOR, Arcus Biosciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-02

Study Completion Date2025-10-18

Study Record Updates

Study Start Date2025-05-02

Study Completion Date2025-10-18

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Healthy Participants