Clinical trial NCT05411146: A Study Investigating the Safety, Absorption, and Elimination of Radioactively Labeled Etrumadenant, a New Compound in the Treatment of Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Etrumadenant
Pharmacokinetics
AB928
Healthy participants
Lead sponsor: Arcus Biosciences, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Gilead Sciences
First posted: 2022-06-09
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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

Primary outcomes:
measure: Excretion of total radioactivity in urine
timeFrame: Up to 25 days
measure: Excretion of total radioactivity in feces
timeFrame: Up to 25 days
measure: Percentage of total radioactivity in urine at selected time points
timeFrame: Up to 25 days
measure: Percentage of total radioactivity in feces at selected time points
timeFrame: Up to 25 days
measure: Mass balance recovery of total radioactivity in urine
timeFrame: Up to 25 days
measure: Mass balance recovery of total radioactivy in feces
timeFrame: Up to 25 days
measure: Number of Participants with Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to 38 days
measure: Number of participants with abnormal electrocardiogram (ECG) readings, abnormal vital signs, abnormal physical examinations and abnormal clinical laboratory tests results
timeFrame: Up to 38 days
Secondary outcomes:
measure: Percentage of total radioactivity in blood
timeFrame: Up to 24 days
measure: Percentage of total radioactivity in plasma
timeFrame: Up to 24 days
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Up to 25 days
measure: Time to Cmax (Tmax)
timeFrame: Up to 25 days
measure: Area Under the Curve From 0 to Last Observed Non-zero Concentration (AUC [0-Last])
timeFrame: Up to 25 days
measure: Area Under the Curve From Time '0' Extrapolated to Infinity (AUC[0-inf])
timeFrame: Up to 25 days
measure: Elimination Half-life (t1/2)
timeFrame: Up to 25 days
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: PRA Health Sciences (PRA) - Early Development Services (EDS)
state: NZ
Study officials:
affiliation: Arcus Biosciences
name: Medical Director
role: STUDY_DIRECTOR
References: