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

Arcus Biosciences

Status and phase: Enrolling; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Quemliclustat

Study type: Interventional

Funder types: Industry

Identifiers

NCT07364214

ARC-24

Details and patient eligibility

About

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.

Enrollment: 8 estimated patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Quemliclustat

Experimental group

Description:

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

Treatment:

Drug: Quemliclustat