Radioactive drug tracking study completed in 8 healthy men
NCT ID NCT07364214
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This completed Phase 1 study looked at how a single dose of the drug Quemliclustat (with a tiny radioactive tag) is broken down and removed from the body. Eight healthy adult men received the drug by IV and provided blood, urine, and stool samples. The goal was purely to understand the drug's metabolism and excretion, not to test any treatment effect.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Quemliclustat (with radioactive tracer)
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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8 people
The number who actually took part.
- Started
-
Feb 2026
- Finished
-
Apr 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
19 to 55 years
- Sex
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Male participants only
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Research Site
Lincoln, Nebraska, 68502, United States
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