Clinical trial NCT06626464: A Study of MK-8189 Human Absorption, Metabolism, and Excretion in Healthy Male Participants (MK-8189-010)
Official title: A Phase 1 Clinical Study to Evaluate the Absorption, Metabolism and Excretion of [14C]MK-8189 in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-10-03
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to learn what happens to MK-8189 in a healthy person's body over time.


Eligibility criteria: Inclusion Criteria:

Key inclusion criteria include but are not limited to the following:

* Is in good health based on medical history, physical examination, VS measurements, and ECGs performed before randomization.
* Has a BMI ≥19 and ≤32 kg/m2, inclusive, at screening

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

* Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
* Has a history of cancer.

Primary outcomes:
measure: Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of MK-8189
timeFrame: Predose and postdose up to 24 hours
measure: Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of MK-8189
timeFrame: Predose and at designated timepoints up to Day 15
measure: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-8189
timeFrame: Predose and at designated timepoints up to Day 15
measure: Maximum Concentration (Cmax) of MK-8189
timeFrame: Predose and at designated timepoints up to Day 15
measure: Apparent Half Life (t½) of MK-8189
timeFrame: Predose and at designated timepoints up to Day 15
measure: Time to Reach Maximum Concentration (Tmax) of MK-8189
timeFrame: Predose and at designated timepoints up to Day 15
measure: Amount Excreted (Ae) in Urine of MK-8189
timeFrame: Predose and at designated timepoints up to Day 15
measure: %Dose Excreted in Urine of MK-8189
timeFrame: Predose and at designated timepoints up to Day 15
measure: Amount Excreted (Ae) in Feces of MK-8189
timeFrame: Predose and at designated timepoints up to Day 15
measure: %Dose Excreted in Feces of MK-8189
timeFrame: Predose and at designated timepoints up to Day 15
measure: Metabolites in Plasma of MK-8189
timeFrame: Predose and at designated timepoints up to Day 15
measure: Metabolites in Urine of MK-8189
timeFrame: Predose and at designated timepoints up to Day 15
measure: Metabolites in Feces of MK-8189
timeFrame: Predose and at designated timepoints up to Day 15
Secondary outcomes:
measure: Number of Participants Experiencing an Adverse Event (AE)
timeFrame: Up to ~ 28 days
measure: Number of Participants Discontinuing Study Treatment due to an AE
timeFrame: Up to ~ 28 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: