Healthy ParticipantsPhase 1NCT07364214
Metabolism, Excretion, and Mass Balance Study of Quemliclustat in Healthy Adult Participants (ARC-24)
A Phase 1 study testing Quemliclustat in people with Healthy Participants, run by Arcus Biosciences, Inc. at 1 site in United States.
Trial summary
The purpose of the study is to investigate the routes of elimination and overall mass balance of 100 mg quemliclustat containing 75 μCi [14C] following a single IV infusion of [14C]-quemliclustat in healthy adult male participants, and to quantify total radioactivity (TRA) in plasma, whole blood, urine, and feces. Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Quemliclustat
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2026to 6 Apr 2026
- 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 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, standard vital signs, and ECGs, as deemed by the PI or designee.
- Participants must follow protocol-specified contraception guidance.
- Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the start of infusion based on participant self-reporting.
- BMI ≥ 18.0 and ≤ 32.0 kg/m2 at the screening visit.
- Understands the study procedures in the Informed Consent Form and is willing and able to comply with the protocol.
Who cannot join
- Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- History or presence of clinically significant medical, surgical, or psychiatric condition or disease in the opinion of the PI or designee.
- History of any illness that, in the opinion of the PI or designee, might confound the results of the study or pose an additional risk to the participant by their participation in the study.
- History or presence of alcohol or drug abuse within the past 2 years prior to the start of infusion.
- History of presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label Study to Characterize the Metabolism, Excretion, and Mass Balance of a Single Intravenous Dose of 100 mg Containing 75 µCi of [14C]-Quemliclustat in Healthy Adult Male Participants
The purpose of the study is to investigate the routes of elimination and overall mass balance of 100 mg quemliclustat containing 75 μCi [14C] following a single IV infusion of [14C]-quemliclustat in healthy adult male participants, and to quantify total radioactivity (TRA) in plasma, whole blood, urine, and feces.
- Conditions
- Healthy Participants
- Being tested
- Quemliclustat
- Keywords
- AB680, Quemliclustat, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuemliclustatDrug
Administered as specified in the treatment arm
| Study group | Role | What they receive |
|---|---|---|
| Quemliclustat | Experimental | Participants will receive a single dose of [14C]-quemliclustat through IV infusion. Receives: Drug: Quemliclustat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of total radioactivity excreted in urine and feces
Measured: Up to 40 days
Total radioactivity in blood
Measured: Up to 40 days
Total radioactivity in plasma
Measured: Up to 40 days
Excretion of total radioactivity in urine
Measured: Up to 40 days
Excretion of total radioactivity in feces
Measured: Up to 40 days
Secondary outcomes (6)
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Measured: Up to 54 days
Area Under the Curve From 0 to Last Observed Non-zero Concentration (AUC [0-Last]) for quemliclustat
Measured: Up to 40 days
Area Under the Curve From Time '0' Extrapolated to Infinity (AUC[0-inf]) for quemliclustat
Measured: Up to 40 days
Maximum Observed Plasma Concentration (Cmax) for quemliclustat
Measured: Up to 40 days
Elimination Half-life (t1/2) for quemliclustat
Measured: Up to 40 days
Excretion of quemliclustat in urine
Measured: Up to 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start3 Feb 2026
- Primary completion6 Apr 2026
- Study completion6 Apr 2026
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)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Arcus Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07364214
- Sponsor's protocol ID
- ARC-24
- Status last verified
- Apr 2026
- First submitted
- 16 Jan 2026
- Last updated
- 1 May 2026
- 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 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study to Characterize the Metabolism, Excretion, and Mass Balance of a Single Intravenous Dose of 100 mg Containing 75 µCi of [14C]-Quemliclustat in Healthy Adult Male Participants
- ClinicalTrials.gov ID
- NCT07364214
- Acronym / sponsor ID
- ARC-24
- Conditions
- Healthy Participants
- Keywords
- AB680, Quemliclustat, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Arcus Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Feb 2026 (actual)
- Primary completion
- 6 Apr 2026 (actual)
- Study completion
- 6 Apr 2026 (actual)
- First posted
- 23 Jan 2026 (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.
The purpose of the study is to investigate the routes of elimination and overall mass balance of 100 mg quemliclustat containing 75 μCi [14C] following a single IV infusion of [14C]-quemliclustat in healthy adult male participants, and to quantify total radioactivity (TRA) in plasma, whole blood, urine, and feces.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quemliclustat | Experimental | Drug: QuemliclustatParticipants will receive a single dose of [14C]-quemliclustat through IV infusion. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, standard vital signs, and ECGs, as deemed by the PI or designee.
- Participants must follow protocol-specified contraception guidance.
- Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the start of infusion based on participant self-reporting.
- BMI ≥ 18.0 and ≤ 32.0 kg/m2 at the screening visit.
- Understands the study procedures in the Informed Consent Form and is willing and able to comply with the protocol.
Key exclusion criteria (6 listed)
- Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- History or presence of clinically significant medical, surgical, or psychiatric condition or disease in the opinion of the PI or designee.
- History of any illness that, in the opinion of the PI or designee, might confound the results of the study or pose an additional risk to the participant by their participation in the study.
- History or presence of alcohol or drug abuse within the past 2 years prior to the start of infusion.
- History of presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds.
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 |
|---|---|---|
| QuemliclustatAdministered as specified in the treatment arm | Drug | Quemliclustat |
Primary outcome
Percentage of total radioactivity excreted in urine and feces
Time frame: Up to 40 days
Total radioactivity in blood
Time frame: Up to 40 days
Total radioactivity in plasma
Time frame: Up to 40 days
Excretion of total radioactivity in urine
Time frame: Up to 40 days
Excretion of total radioactivity in feces
Time frame: Up to 40 days
6 secondary outcomes
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 54 days
Area Under the Curve From 0 to Last Observed Non-zero Concentration (AUC [0-Last]) for quemliclustat
Time frame: Up to 40 days
Area Under the Curve From Time '0' Extrapolated to Infinity (AUC[0-inf]) for quemliclustat
Time frame: Up to 40 days
Maximum Observed Plasma Concentration (Cmax) for quemliclustat
Time frame: Up to 40 days
Elimination Half-life (t1/2) for quemliclustat
Time frame: Up to 40 days
Excretion of quemliclustat in urine
Time frame: Up to 40 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 1 May 2026.
- 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 Quemliclustat in people with Healthy Participants, run by Arcus Biosciences, Inc. at 1 site in United States.
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 1 May 2026. 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 United States. 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?
Percentage of total radioactivity excreted in urine and feces (time frame: Up to 40 days). The study lists 5 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 1 May 2026.