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

NCT ID: NCT06919991

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-02

Study Completion Date

2025-10-18

Brief Summary

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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

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Conditions

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Healthy Participants

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Casdatifan-Itraconazole-Phenytoin

Participants will receive casdatifan, itraconazole, and phenytoin.

Group Type EXPERIMENTAL

Casdatifan

Intervention Type DRUG

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

Itraconazole

Intervention Type DRUG

Administered as multiple doses in treatment Period 2

Phenytoin

Intervention Type DRUG

Administered as multiple doses in treatment Period 3

Interventions

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Casdatifan

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

Intervention Type DRUG

Itraconazole

Administered as multiple doses in treatment Period 2

Intervention Type DRUG

Phenytoin

Administered as multiple doses in treatment Period 3

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Arcus Biosciences, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Arcus Biosciences

Locations

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Celerion

Tempe, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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ARC-29

Identifier Type: -

Identifier Source: org_study_id