Status:

COMPLETED

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

Lead Sponsor:

Arcus Biosciences, Inc.

Conditions:

Cancer

Eligibility:

All Genders

18-55 years

Phase:

PHASE1

Brief 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 volunt...

Eligibility Criteria

Inclusion

  • Key
  • 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

  • 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.

Key Trial Info

Start Date :

October 16 2023

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 23 2024

Estimated Enrollment :

32 Patients enrolled

Trial Details

Trial ID

NCT06004921

Start Date

October 16 2023

End Date

February 23 2024

Last Update

August 28 2024

Active Locations (1)

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1

Quotient Sciences - Nottingham

Nottingham, United Kingdom