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

NCT07364214 | Completed Phase 1 FDA Drug

• 1 other identifier: ARC-24
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Keywords

AB680; Quemliclustat; Pharmacokinetics

Outcome Measures

Primary Outcomes (5)

• 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 (6)

• 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

• Area Under the Curve From Time '0' Extrapolated to Infinity (AUC[0-inf]) for quemliclustat

  Up to 40 days

• Maximum Observed Plasma Concentration (Cmax) for quemliclustat

  Up to 40 days

• Elimination Half-life (t1/2) for quemliclustat

  Up to 40 days

Study Arms (1)

Quemliclustat

EXPERIMENTAL

Participants will receive a single dose of \[14C\]-quemliclustat through IV infusion.

Drug: Quemliclustat

Interventions

Quemliclustat DRUG

Administered as specified in the treatment arm

Quemliclustat

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arcus Biosciences, Inc.: lead

Study Sites (1)

Research Site

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Interventions

quemliclustat

Study Officials

• Medical Director

  Arcus Biosciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: January 23, 2026
• Study Start: February 3, 2026
• Primary Completion: April 6, 2026
• Study Completion: April 6, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

US (1)