Clinical trial NCT06777602: A Clinical Study To Understand How Radiolabeled MK-5475 Is Taken Up By The Body, Broken Down And Then Removed From The Body in Healthy Participants (MK-5475-011)
Official title: An Open-label Phase 1 IV Study to Evaluate Metabolism, Excretion, and Mass Balance of [14C]MK-5475 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2025-01-16
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this study is to understand how radiolabeled MK-5475 administered intravenously (IV) is taken up by the body, broken down and then removed from the body in healthy male participants. The study also aims to understand how much of the compound is broken down and how much leaves the body unchanged.


Eligibility criteria: Inclusion Criteria:

* Is in good health.
* Body mass index (BMI) \>18 and ≤32 kg/m2, inclusive.

Exclusion Criteria:

* Has history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
* Has significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food.
* Has had a major surgery and/or donated or lost 1 unit of blood (approximately 500 mL) or blood products within 4 weeks prior to the prestudy (screening).
* Has history of exposure to significant diagnostic or therapeutic radiation or current employment in a job requiring radiation exposure monitoring within 12 months prior to check-in.
* Has participated in more than 3 radiolabeled drug studies in the last 12 months.

Primary outcomes:
measure: Amount Excreted in Urine (Aeu)
timeFrame: At designated time points (Up to ~ 23 days)
measure: Cumulative Aeu
timeFrame: At designated time points (Up to ~ 23 days)
measure: Percentage Excreted in Urine (feu)
timeFrame: At designated time points (Up to ~ 23 days)
measure: Cumulative feu
timeFrame: At designated time points (Up to ~ 23 days)
measure: Amount Excreted in Feces (Aef)
timeFrame: At designated time points (Up to ~ 23 days)
measure: Cumulative Aef
timeFrame: At designated time points (Up to ~ 23 days)
measure: Cumulative Fef
timeFrame: At designated time points (Up to ~ 23 days)
measure: AUC0-t
timeFrame: At designated time points (Up to ~ 23 days)
measure: AUC0-infinity
timeFrame: At designated time points (Up to ~ 23 days)
measure: Maximum Plasma Concentration (Cmax)
timeFrame: At designated time points (Up to ~ 23 days)
measure: Half-life t1/2
timeFrame: At designated time points (Up to ~ 23 days)
measure: Time to Maximum Plasma Concentration (Tmax),
timeFrame: At designated time points (Up to ~ 23 days)
measure: Apparent Total Clearance (CL; MK-5475 only)
timeFrame: At designated time points (Up to ~ 23 days)
measure: Apparent Volume of Distribution (Vz; MK-5475 only)
timeFrame: At designated time points (Up to ~ 23 days)
measure: AUC0-infinity Plasma [14C]MK-5475/Total Radioactivity Ratio
timeFrame: At designated time points (Up to ~ 23 days)
Secondary outcomes:
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to ~ 30 days
measure: Number of Participants Who Discontinue Study Due to an AE
timeFrame: Up to ~ 30 days
Other outcomes:
Locations:
city: Madison
country: United States
facility: Labcorp Clinical Research Unit Inc. (Site 0001)
state: Wisconsin
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: