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

Cancer Clinical Trial

— ARC-26  

Official title:

A Phase 1, Double-Blinded, Randomised, Placebo-Controlled, Single Ascending Dose (SAD) Study in Healthy Subjects to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of AB801

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06004921
• Other study ID #: ARC-26
• Status: Completed
• Phase: Phase 1
• Start date: October 16, 2023
• Est. completion date: February 15, 2024

Study information

• Verified date: February 2024
• Source: Arcus Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 15, 2024
• Est. primary completion date: February 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• AB801
Administered as specified in the treatment arm
• Placebo
Administered as specified in the treatment arm

Locations

Country	Name	City	State
United Kingdom	Quotient Sciences - Nottingham	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Arcus Biosciences, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events (AEs)		Up to 30 days
Primary	Area Under the Plasma Drug Concentration-Time Curve (AUC)		Predose, Up to 120 hours postdose
Primary	Maximum Concentration (Cmax) in Plasma		Predose, Up to 120 hours postdose
Primary	Time to Maximum Concentration (Tmax) in Plasma		Predose, Up to 120 hours postdose
Primary	Half-Life Time (t1/2)		Predose, Up to 120 hours postdose
Secondary	Change from Baseline in Holter Electrocardiogram Monitoring Scale		Predose up to 25 hours postdose