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Completed

NCT Number: NCT07364214

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

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.

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Key information

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quemliclustat

Drug

Administered as specified in the treatment arm

Primary outcomes

  1. Percentage of total radioactivity excreted in urine and feces

    Time frame: Up to 40 days

  2. Total radioactivity in blood

    Time frame: Up to 40 days

  3. Total radioactivity in plasma

    Time frame: Up to 40 days

  4. Excretion of total radioactivity in urine

    Time frame: Up to 40 days

  5. Excretion of total radioactivity in feces

    Time frame: Up to 40 days

Secondary outcomes

  1. Number of Participants with Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to 54 days

  2. Area Under the Curve From 0 to Last Observed Non-zero Concentration (AUC [0-Last]) for quemliclustat

    Time frame: Up to 40 days

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

    Time frame: Up to 40 days

  4. Maximum Observed Plasma Concentration (Cmax) for quemliclustat

    Time frame: Up to 40 days

  5. Elimination Half-life (t1/2) for quemliclustat

    Time frame: Up to 40 days

  6. Excretion of quemliclustat in urine

    Time frame: Up to 40 days

Sponsors and collaborators

Lead sponsor

Arcus Biosciences, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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