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

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05411146
• Other study ID #: ARC-19
• Secondary ID: 2022-000822-50
• Status: Completed
• Phase: Phase 1
• Start date: May 25, 2022
• Est. completion date: July 7, 2022

Study information

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

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: July 7, 2022
• Est. primary completion date: July 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• [14C]-etrumadenant
Administered as specified in the treatment arm.

Locations

Country	Name	City	State
Netherlands	PRA Health Sciences (PRA) - Early Development Services (EDS)	Groningen	NZ

Sponsors (2)

Lead Sponsor	Collaborator
Arcus Biosciences, Inc.	Gilead Sciences

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Excretion of total radioactivity in urine		Up to 25 days
Primary	Excretion of total radioactivity in feces		Up to 25 days
Primary	Percentage of total radioactivity in urine at selected time points		Up to 25 days
Primary	Percentage of total radioactivity in feces at selected time points		Up to 25 days
Primary	Mass balance recovery of total radioactivity in urine		Up to 25 days
Primary	Mass balance recovery of total radioactivy in feces		Up to 25 days
Primary	Number of Participants with Treatment Emergent Adverse Events (TEAEs)		Up to 38 days
Primary	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	Percentage of total radioactivity in blood		Up to 24 days
Secondary	Percentage of total radioactivity in plasma		Up to 24 days
Secondary	Maximum Observed Plasma Concentration (Cmax)		Up to 25 days
Secondary	Time to Cmax (Tmax)		Up to 25 days
Secondary	Area Under the Curve From 0 to Last Observed Non-zero Concentration (AUC [0-Last])		Up to 25 days
Secondary	Area Under the Curve From Time '0' Extrapolated to Infinity (AUC[0-inf])		Up to 25 days
Secondary	Elimination Half-life (t1/2)		Up to 25 days

External Links

•   ARC-19 - Lay Summary (English Version)