Clinical Trials/NCT05411146

NCT05411146

Completed

Phase 1

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

Arcus Biosciences, Inc.1 site in 1 country8 target enrollmentMay 25, 2022

ConditionsHealthy Participants

Interventions[14C]-etrumadenant

Drugs[14C]-etrumadenant

Overview

Phase: Phase 1
Intervention: [14C]-etrumadenant
Conditions: Healthy Participants
Sponsor: Arcus Biosciences, Inc.
Enrollment: 8
Locations: 1
Primary Endpoint: Mass balance recovery of total radioactivy in feces
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

May 25, 2022

End Date

July 7, 2022

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Arcus Biosciences, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

[14C]-etrumadenant

Participants will receive a single dose of \[14C\]-etrumadenant.

Intervention: [14C]-etrumadenant

Outcomes

Primary Outcomes

Mass balance recovery of total radioactivy in feces

Time Frame: Up to 25 days

Excretion of total radioactivity in urine

Time Frame: Up to 25 days

Excretion of total radioactivity in feces

Time Frame: Up to 25 days

Percentage of total radioactivity in urine at selected time points

Time Frame: Up to 25 days

Percentage of total radioactivity in feces at selected time points

Time Frame: Up to 25 days

Mass balance recovery of total radioactivity in urine

Time Frame: Up to 25 days

Number of Participants with Treatment Emergent Adverse Events (TEAEs)

Time Frame: Up to 38 days

Number of participants with abnormal electrocardiogram (ECG) readings, abnormal vital signs, abnormal physical examinations and abnormal clinical laboratory tests results

Time Frame: Up to 38 days

Secondary Outcomes

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)
Percentage of total radioactivity in blood(Up to 24 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)