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

NCT05411146 | Completed Phase 1 FDA Drug

• 2 other identifiers: ARC-192022-000822-50
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Participants

Keywords

Etrumadenant; Pharmacokinetics; AB928; Healthy participants

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (7)

• 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

Study Arms (1)

[14C]-etrumadenant

EXPERIMENTAL

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

Drug: [14C]-etrumadenant

Interventions

[14C]-etrumadenant DRUG

Administered as specified in the treatment arm.

Also known as: [14C]-AB928

[14C]-etrumadenant

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arcus Biosciences, Inc.: lead
• Gilead Sciences: collaborator

Study Sites (1)

PRA Health Sciences (PRA) - Early Development Services (EDS)

Groningen, NZ, 9728, Netherlands

Location

Related Links

• ARC-19 - Lay Summary (English Version)

Study Officials

• Medical Director

  Arcus Biosciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: June 9, 2022
• Study Start: May 25, 2022
• Primary Completion: July 7, 2022
• Study Completion: July 7, 2022
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

NL (1)