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

Arcus Biosciences

Status and phase

Completed

Phase 1

Conditions

Healthy Participants

Treatments

Drug: [14C]-etrumadenant

Study type

Interventional

Funder types

Industry

Identifiers

2022-000822-50 (EudraCT Number)

ARC-19

Details and patient eligibility

About

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

Enrollment

8 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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