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NCT Number: NCT07641881

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

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.

Recruiting

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Tempe, Arizona, 85283, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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.

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 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.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Treatment and study plan

casdatifan

Drug

Administered as specified in the treatment arm

Other names: AB521

Primary outcomes

  1. Maximum observed concentration for casdatifan

    Time frame: Up to 168 hours post each dose

  2. Area under the concentration-time curve for casdatifan

    Time frame: Up to 168 hours post each dose

Secondary outcomes

  1. Time to reach Cmax (Tmax) for casdatifan

    Time frame: Up to 168 hours post each dose

  2. Lag time (Tlag) for casdatifan

    Time frame: Up to 168 hours post each dose

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

    Time frame: Up to 168 hours post each dose

  4. Percent of AUC0-inf extrapolated for casdatifan

    Time frame: Up to 168 hours post each dose

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

    Time frame: Up to 168 hours post each dose

  6. Apparent total clearance after extravascular (oral) administration (CL/F) for casdatifan

    Time frame: Up to 168 hours post each dose

  7. Apparent total clearance after extravascular (oral) administration (Vz/F) for casdatifan

    Time frame: Up to 168 hours post each dose

  8. Number of participants experiencing Adverse Events (AEs)

    Time frame: Up to 43 days

Study contacts

Contact information is provided by the study sponsor or research team.

Medical Director

CONTACT

[email protected]

+1-510-462-3330

Sponsors and collaborators

Lead sponsor

Arcus Biosciences, Inc.

Industry

Collaborators

  • Taiho Pharmaceutical Co., Ltd.

Registry information

Official study title

A Phase 1, Open-Label, Randomized, Single-Dose, Three-Treatment, Three-Period, Six-Sequence Crossover Pharmacokinetic Study to Evaluate the Bioequivalence of Two Casdatifan (AB521) Tablet Strengths and Food Effect in Healthy Adult Participants

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 11, 2026
Registry last updated
Jun 17, 2026

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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