Metabolism, Excretion, and Mass Balance Study of Quemliclustat in Healthy Adult Participants (ARC… (NCT07364214) | Clinical Trial Compass
CompletedPhase 1
Metabolism, Excretion, and Mass Balance Study of Quemliclustat in Healthy Adult Participants (ARC-24)
United States8 participantsStarted 2026-02-03
Plain-language 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.
Who can participate
Age range
19 Years – 55 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of total radioactivity excreted in urine and feces