A Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of AB801 in Healthy Volunteers

• Status: Completed
• Trial end date: 2024-02-15
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to determine the safety and tolerability of AB801, and to understand the pharmacokinetic (PK) profile of AB801 when taken as a capsule and tablet in healthy volunteers.

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

Details

• Lead Sponsor: Arcus Biosciences, Inc.

Criteria

Key Inclusion Criteria:

• Healthy as determined by medical evaluation by study physician

• Body mass index (BMI) of 18.0 to 32.0 kilogram (kg)/meter (m)^2 as measured at screening

• Weight ≥ 50 kg at screening

• Must agree to adhere to the protocol defined contraception requirements

Key Exclusion Criteria:

• Do not have suitable veins for multiple venepunctures/cannulation as assessed by the study physician

• Prolonged QT interval defined as mean Corrected QT interval by Fridericia's formula (QTcF) ≥ 450 msec for males and > 470 millisecond (msec) for females at screening and pre-dose

• Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the study physician

• Received any study medicine in a clinical research study within the last 90 days

• Taking, or have taken, any prescribed or over-the-counter drugs including gastric acid reducing agents and including CYP3A inhibitor and/or inducers

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