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Metabolism, Excretion, and Mass Balance Study of Quemliclustat in Healthy Adult Participants (ARC-24) | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1

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

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

NCT07364214•Arcus Biosciences, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

19 - 55 years

Sex

MALE

Healthy Volunteers

Yes

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.

Locations (1)

Celerion

Lincoln, Nebraska, United States

Key Dates

Start Date

February 3, 2026

Primary Completion Date

March 1, 2026

Completion Date

April 1, 2026

Last Updated

March 4, 2026

Enrollment

ESTIMATED participants

Conditions

Healthy Participants

Interventions

Quemliclustat

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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