Metabolism, Excretion, and Mass Balance Study of Quemlicl... | NCT07364214

Studies
Metabolism, Excretion, and Mass Balance Study of Quemliclustat in Healthy Adult Participants (ARC-24)

NCT07364214

Sponsor

Arcus Biosciences, Inc.

Status

Completed

Last Update Posted

May 1, 2026Actual

Enrollment

8Actual

Phase

Phase 1

Conditions

Healthy Participants

Interventions

Quemliclustat

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 3, 2026Actual

Primary Completion Date

Apr 6, 2026Actual

Completion Date

Apr 6, 2026Actual

First Submitted Date

Jan 16, 2026

First Submission Date that Met QC Criteria

Jan 16, 2026

First Posted Date

Jan 23, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2026

Last Update Posted Date

May 1, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Quemliclustat	Experimental	Participants will receive a single dose of [14C]-quemliclustat through IV infusion.	Drug: Quemliclustat

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Quemliclustat	Drug	Administered as specified in the treatment arm	Quemliclustat

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of total radioactivity excreted in urine and feces		Up to 40 days
Total radioactivity in blood		Up to 40 days
Total radioactivity in plasma		Up to 40 days
Excretion of total radioactivity in urine		Up to 40 days
Excretion of total radioactivity in feces		Up to 40 days

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants with Treatment Emergent Adverse Events (TEAEs)		Up to 54 days
Area Under the Curve From 0 to Last Observed Non-zero Concentration (AUC [0-Last]) for quemliclustat		Up to 40 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Medical Director	Arcus Biosciences	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Lincoln	Nebraska	68502	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

Time Frame

Not provided

Access Criteria

Not provided

URL

https://trials.arcusbio.com/our-transparency-policy