A Relative Bioavailability Study and Food Effect Study of AB521 in Healthy Adult Volunteers (ARC-28)

Arcus Biosciences

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: casdatifan

Study type: Interventional

Funder types: Industry

Identifiers

NCT05999513

ARC-28

Details and patient eligibility

About

The primary purpose of this study is to compare the single-dose pharmacokinetics (PK) of casdatifan tablet versus the casdatifan capsule, and to evaluate the effect of food on the single-dose PK of casdatifan tablet in healthy adult volunteers.

Enrollment: 24 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key 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 volunteer self-reporting
• Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kilogram (kg)/square meter (m^2) at the screening visit, with body weight ≥ 45 kg
• Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, and ECGs, as deemed by the study physician
• Able to swallow multiple capsules and tablets
• Has adequate peripheral venous access

Key Exclusion Criteria:

• Has active neoplastic disease or history of neoplastic disease within 5 years of the screening visit (except for basal or squamous cell carcinoma of the skin or carcinoma in situ that has been definitively treated with standard of care)
• Has abnormal liver enzyme test results or hematology values at the time of enrollment
• Has a history of additional risk factors for Torsades de pointes (example: heart failure, hypokalemia, family history of Long QT Syndrome)
• Malabsorption condition that would alter the absorption of orally administered medications at the discretion of the study physician
• Participation in another clinical study within 90 days or within 5 half-lives (if known), prior to the first dosing, whichever is longer. The 90-day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of the current study

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Casdatifan - Sequence ABC

Experimental group

Description:

Participants will sequentially receive casdatifan capsules fasted (Treatment A), followed by casdatifan tablets fasted (Treatment B), followed by casdatifan tablets fed (Treatment C)

Treatment:

Drug: casdatifan

Casdatifan - Sequence BCA

Experimental group

Description:

Participants will sequentially receive Treatment B, followed by Treatment C, then Treatment A

Treatment:

Drug: casdatifan

Casdatifan - Sequence CAB

Experimental group

Description:

Participants will sequentially receive Treatment C, followed by Treatment A, then Treatment B

Treatment:

Drug: casdatifan