A Relative Bioavailability Study and Food Effect Study of AB521 in Healthy Adult Volunteers

• Status: Completed
• Trial end date: 2023-10-31
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to compare the single-dose pharmacokinetics (PK) of AB521 tablet versus the AB521 capsule, and to evaluate the effect of food on the single-dose PK of AB521 tablet in healthy adult volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Arcus Biosciences, Inc.

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.