Healthy ParticipantsPhase 1NCT05411146
A Study Investigating the Safety, Absorption, and Elimination of Radioactively Labeled Etrumadenant, a New Compound in the Treatment of Cancer
A Phase 1 study testing [14C]-etrumadenant in people with Healthy Participants, run by Arcus Biosciences, Inc. at 1 site in Netherlands.
Trial summary
This study will assess absorption, metabolism, and excretion of Radioactively Labeled Etrumadenant in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- [14C]-etrumadenant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 May 2022to 7 Jul 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
PRA Health Sciences (PRA) - Early Development Services (EDS)
Groningen, NZ, 9728
About this study
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
This study will assess absorption, metabolism, and excretion of Radioactively Labeled Etrumadenant in healthy volunteers.
- Conditions
- Healthy Participants
- Being tested
- [14C]-etrumadenant
- Keywords
- Etrumadenant, Pharmacokinetics, AB928, Healthy participants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-etrumadenantDrug
Also called [14C]-AB928
Administered as specified in the treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| [14C]-etrumadenant | Experimental | Participants will receive a single dose of [14C]-etrumadenant. Receives: Drug: [14C]-etrumadenant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Excretion of total radioactivity in urine
Measured: Up to 25 days
Excretion of total radioactivity in feces
Measured: Up to 25 days
Percentage of total radioactivity in urine at selected time points
Measured: Up to 25 days
Percentage of total radioactivity in feces at selected time points
Measured: Up to 25 days
Mass balance recovery of total radioactivity in urine
Measured: Up to 25 days
Mass balance recovery of total radioactivy in feces
Measured: Up to 25 days
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Measured: Up to 38 days
Number of participants with abnormal electrocardiogram (ECG) readings, abnormal vital signs, abnormal physical examinations and abnormal clinical laboratory tests results
Measured: Up to 38 days
Secondary outcomes (7)
Percentage of total radioactivity in blood
Measured: Up to 24 days
Percentage of total radioactivity in plasma
Measured: Up to 24 days
Maximum Observed Plasma Concentration (Cmax)
Measured: Up to 25 days
Time to Cmax (Tmax)
Measured: Up to 25 days
Area Under the Curve From 0 to Last Observed Non-zero Concentration (AUC [0-Last])
Measured: Up to 25 days
Area Under the Curve From Time '0' Extrapolated to Infinity (AUC[0-inf])
Measured: Up to 25 days
Elimination Half-life (t1/2)
Measured: Up to 25 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start25 May 2022
- Primary completion7 Jul 2022
- Study completion7 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arcus Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Arcus Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05411146
- Sponsor's protocol ID
- ARC-19
- Other IDs
- 2022-000822-50
- Status last verified
- May 2024
- First submitted
- 10 May 2022
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan \[SAP\], Clinical Study Report \[CSR\]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. For more information, please visit our website.
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05411146
- Acronym / sponsor ID
- ARC-19
- Conditions
- Healthy Participants
- Keywords
- Etrumadenant, Pharmacokinetics, AB928, Healthy participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Arcus Biosciences, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Gilead Sciences
- Study start
- 25 May 2022 (actual)
- Primary completion
- 7 Jul 2022 (actual)
- Study completion
- 7 Jul 2022 (actual)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess absorption, metabolism, and excretion of Radioactively Labeled Etrumadenant in healthy volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]-etrumadenant | Experimental | Drug: [14C]-etrumadenantParticipants will receive a single dose of [14C]-etrumadenant. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C]-etrumadenantAlso: [14C]-AB928Administered as specified in the treatment arm. | Drug | [14C]-etrumadenant |
Primary outcome
Excretion of total radioactivity in urine
Time frame: Up to 25 days
Excretion of total radioactivity in feces
Time frame: Up to 25 days
Percentage of total radioactivity in urine at selected time points
Time frame: Up to 25 days
Percentage of total radioactivity in feces at selected time points
Time frame: Up to 25 days
Mass balance recovery of total radioactivity in urine
Time frame: Up to 25 days
Mass balance recovery of total radioactivy in feces
Time frame: Up to 25 days
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 38 days
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
7 secondary outcomes
Percentage of total radioactivity in blood
Time frame: Up to 24 days
Percentage of total radioactivity in plasma
Time frame: Up to 24 days
Maximum Observed Plasma Concentration (Cmax)
Time frame: Up to 25 days
Time to Cmax (Tmax)
Time frame: Up to 25 days
Area Under the Curve From 0 to Last Observed Non-zero Concentration (AUC [0-Last])
Time frame: Up to 25 days
Area Under the Curve From Time '0' Extrapolated to Infinity (AUC[0-inf])
Time frame: Up to 25 days
Elimination Half-life (t1/2)
Time frame: Up to 25 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- ARC-19 - Lay Summary (English Version)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan [SAP], Clinical Study Report [CSR]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. For more information, please visit our website.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Arcus Biosciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C]-etrumadenant in people with Healthy Participants, run by Arcus Biosciences, Inc. at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Excretion of total radioactivity in urine (time frame: Up to 25 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.