A Bioequivalence Study Between Two Casdatifan Tablet Strengths and Food Effect Study of Casdatifan in Healthy Adult Participants

NCT07641881 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ARC-30
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the single-dose pharmacokinetics (PK) of casdatifan 100 mg versus four 25 mg tablets under fasting conditions in healthy adult participants, and to evaluate the effect of food on the single-dose PK of casdatifan 100 mg administered as four 25 mg tablets in healthy adult participants.

Conditions

Healthy Participants

Keywords

Casdatifan; AB521; HIF-2α; Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• Maximum observed concentration for casdatifan

  Up to 168 hours post each dose

• Area under the concentration-time curve for casdatifan

  Up to 168 hours post each dose

Secondary Outcomes (8)

• Time to reach Cmax (Tmax) for casdatifan

  Up to 168 hours post each dose

• Lag time (Tlag) for casdatifan

  Up to 168 hours post each dose

• Apparent first-order terminal elimination rate constant (Kel) for casdatifan

  Up to 168 hours post each dose

• Percent of AUC0-inf extrapolated for casdatifan

  Up to 168 hours post each dose

• Apparent first-order terminal elimination half-life (t½) for casdatifan

  Up to 168 hours post each dose

Study Arms (3)

Treatment A

EXPERIMENTAL

Participants will receive 4 X 25 mg tablets of casdatifan.

Drug: Casdatifan

Treatment B

EXPERIMENTAL

Participants will receive 1 X 100 mg tablets of casdatifan.

Drug: Casdatifan

Treatment C

EXPERIMENTAL

Participants will receive 4 X 25 mg tablets of casdatifan under fed conditions.

Drug: Casdatifan

Interventions

Casdatifan DRUG

Administered as specified in the treatment arm

Also known as: AB521

Treatment A; Treatment B; Treatment C

Eligibility Criteria

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

You may qualify if:

• 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.
• Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, standard vital signs, and ECGs, as deemed by the PI or designee.
• Able to swallow multiple tablets.
• Has adequate peripheral venous access.

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 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 of asthma or chronic obstructive pulmonary disease (including childhood), clinically significant food allergies or anaphylaxis, as deemed by PI or designee.
• Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of asymptomatic gallstones).
• Seizure (excluding simple febrile seizure), epilepsy, severe head injury, multiple sclerosis, or other known neurological conditions which the PI or designee considers to be clinically significant.

Sponsors & Collaborators

• Arcus Biosciences, Inc.: lead
• Taiho Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Research Site

Tempe, Arizona, 85283, United States

RECRUITING

Study Officials

• Medical Director

  Arcus Biosciences

  STUDY DIRECTOR

Central Study Contacts

Medical Director

CONTACT

+1-510-462-3330; ClinicalTrialInquiry@arcusbio.com

Study Design

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

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 11, 2026
• Study Start: May 29, 2026
• Primary Completion: July 1, 2026
• Study Completion: July 1, 2026
• Last Updated: June 17, 2026

Record last verified: 2026-05

Data Sharing

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

Locations

US (1)