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Completed

NCT Number: NCT05411146

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

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

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Key information

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

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

Groningen, NZ, 9728, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[14C]-etrumadenant

Drug

Administered as specified in the treatment arm.

Other names: [14C]-AB928

Primary outcomes

  1. Excretion of total radioactivity in urine

    Time frame: Up to 25 days

  2. Excretion of total radioactivity in feces

    Time frame: Up to 25 days

  3. Percentage of total radioactivity in urine at selected time points

    Time frame: Up to 25 days

  4. Percentage of total radioactivity in feces at selected time points

    Time frame: Up to 25 days

  5. Mass balance recovery of total radioactivity in urine

    Time frame: Up to 25 days

  6. Mass balance recovery of total radioactivy in feces

    Time frame: Up to 25 days

  7. Number of Participants with Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to 38 days

  8. 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

  1. Percentage of total radioactivity in blood

    Time frame: Up to 24 days

  2. Percentage of total radioactivity in plasma

    Time frame: Up to 24 days

  3. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Up to 25 days

  4. Time to Cmax (Tmax)

    Time frame: Up to 25 days

  5. Area Under the Curve From 0 to Last Observed Non-zero Concentration (AUC [0-Last])

    Time frame: Up to 25 days

  6. Area Under the Curve From Time '0' Extrapolated to Infinity (AUC[0-inf])

    Time frame: Up to 25 days

  7. Elimination Half-life (t1/2)

    Time frame: Up to 25 days

Sponsors and collaborators

Lead sponsor

Arcus Biosciences, Inc.

Industry

Collaborators

  • Gilead Sciences

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 9, 2022
Registry last updated
May 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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