Healthy Participants
Conditions
Keywords
Etrumadenant, Pharmacokinetics, AB928, Healthy participants
Brief summary
This study will assess absorption, metabolism, and excretion of Radioactively Labeled Etrumadenant in healthy volunteers.
Interventions
DRUG[14C]-etrumadenant
Administered as specified in the treatment arm.
Sponsors
Gilead Sciences
Arcus Biosciences, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with abnormal electrocardiogram (ECG) readings, abnormal vital signs, abnormal physical examinations and abnormal clinical laboratory tests results | Up to 38 days |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Percentage of total radioactivity in blood | Up to 24 days |
Countries
Netherlands
Outcome results
None listed