A Study Investigating the Safety, Absorption, and Elimination of Radioactively Labeled Etrumadenant, a New Compound in the Treatment of Cancer

A Phase 1, Open-label Study to Assess the Absorption, Metabolism, and Excretion, Including the Mass Balance, of a Single Oral Dose of [14C]-Etrumadenant in Healthy Male Subjects

This study will assess absorption, metabolism, and excretion of Radioactively Labeled Etrumadenant in healthy volunteers.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: [14C]-etrumadenant

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • NZ
    • Groningen, NZ, Netherlands, 9728
      • PRA Health Sciences (PRA) - Early Development Services (EDS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• BMI between 18.0 to 32.0 kg/m2
• Body weight ≥50 kg
• Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, ECG, and vital signs, as judged by the Investigator.
• All clinical laboratory test results within the normal range or showing no clinically relevant deviations as judged by the Investigator.
• Male subjects, if not surgically sterilized, must agree to use adequate contraception and not donate sperm from (first) admission to the clinical research center until 90 days after the study drug administration. Adequate contraception for the male subject (and his female partner, if she is of childbearing potential) is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm, a cervical cap, or a condom. Total abstinence from heterosexual intercourse, in accordance with the lifestyle of the subject, is also acceptable.

Exclusion Criteria:

• Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, and alcohol) at screening or admission to the clinical research center.
• Significant and/or acute illness within 5 days prior to drug administration that may impact safety assessments, in the opinion of the Investigator.
• Irregular defecation pattern (less than once per 2 days).
• For a study with a radiation burden of superior to 0.1 mSv, the subject will be excluded if he participated in another study with a radiation burden of superior to 0.1 mSv and inferior or equal to 1 mSv in the period of 1 year prior to screening; a radiation burden of superior to 1.1 mSv and inferior or equal 2 mSv in the period of 2 years prior to screening; a radiation burden of superior to 2.1 mSv and inferior or equal 3 mSv in the period of 3 years prior to screening.
• Exposure to radiation for diagnostic reasons (except dental X rays and plain X rays of thorax and bony skeleton [excluding spinal column]), during work, or during participation in a clinical study in the period of 1 year prior to screening.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [14C]-etrumadenant; Participants will receive a single dose of [14C]-etrumadenant.	Drug: [14C]-etrumadenant; Administered as specified in the treatment arm.; Other Names: [14C]-AB928

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Excretion of total radioactivity in urine	Up to 25 days
Excretion of total radioactivity in feces	Up to 25 days
Percentage of total radioactivity in urine at selected time points	Up to 25 days
Percentage of total radioactivity in feces at selected time points	Up to 25 days
Mass balance recovery of total radioactivity in urine	Up to 25 days
Mass balance recovery of total radioactivy in feces	Up to 25 days
Number of Participants with Treatment Emergent Adverse Events (TEAEs)	Up to 38 days
Number of participants with abnormal electrocardiogram (ECG) readings, abnormal vital signs, abnormal physical examinations and abnormal clinical laboratory tests results	Up to 38 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of total radioactivity in blood	Up to 24 days
Percentage of total radioactivity in plasma	Up to 24 days
Maximum Observed Plasma Concentration (Cmax)	Up to 25 days
Time to Cmax (Tmax)	Up to 25 days
Area Under the Curve From 0 to Last Observed Non-zero Concentration (AUC [0-Last])	Up to 25 days
Area Under the Curve From Time '0' Extrapolated to Infinity (AUC[0-inf])	Up to 25 days
Elimination Half-life (t1/2)	Up to 25 days

Collaborators and Investigators

• Sponsor: Arcus Biosciences, Inc.
• Collaborators: Gilead Sciences
• Investigators: Study Director: Medical Director, Arcus Biosciences

Publications and helpful links

Helpful Links

• ARC-19 - Lay Summary (English Version)

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2022
• Primary Completion (Actual): July 7, 2022
• Study Completion (Actual): July 7, 2022

Study Registration Dates

• First Submitted: May 10, 2022
• First Submitted That Met QC Criteria: June 5, 2022
• First Posted (Actual): June 9, 2022

Study Record Updates

• Last Update Posted (Actual): May 24, 2024
• Last Update Submitted That Met QC Criteria: May 23, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Healthy participants; Etrumadenant; AB928
• Other Study ID Numbers: ARC-19; 2022-000822-50 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan [SAP], Clinical Study Report [CSR]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.

For more information, please visit our website.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No