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

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

Official Title
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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

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: [14C]-etrumadenant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [14C]-etrumadenant<br>Participants will receive a single dose of [14C]-etrumadenant. | Drug: [14C]-etrumadenant<br>* Administered as specified in the treatment arm.<br>* Other names: [14C]-AB928;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Etrumadenant, Pharmacokinetics, AB928, Healthy participants