A Study of MK-8189 Human Absorption, Metabolism, and Excretion in Healthy Male Participants (MK-8189-010)
- Registration Number
- NCT06626464
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this study is to learn what happens to MK-8189 in a healthy person's body over time.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
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
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Carbon-14 radiolabeled [14C] MK-8189 [14C]MK-8189 Participants receive a dose of 4.5-mg immediate release (IR) (\~ 50 μCi) orally on Day 1.
- Primary Outcome Measures
Name Time Method Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of MK-8189 Predose and postdose up to 24 hours Blood samples will be collected to determine the AUC0-24 of MK-8189.
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of MK-8189 Predose and at designated timepoints up to Day 15 Blood samples will be collected to determine the AUClast of MK-8189.
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-8189 Predose and at designated timepoints up to Day 15 Blood samples will be collected to determine the AUC0-inf of MK-8189.
Maximum Concentration (Cmax) of MK-8189 Predose and at designated timepoints up to Day 15 Blood samples will be collected to determine the Cmax of MK-8189.
Apparent Half Life (t½) of MK-8189 Predose and at designated timepoints up to Day 15 Blood samples will be collected to determine the t1/2 of MK-8189.
Time to Reach Maximum Concentration (Tmax) of MK-8189 Predose and at designated timepoints up to Day 15 Blood samples will be collected to determine the Tmax of MK-8189.
Amount Excreted (Ae) in Urine of MK-8189 Predose and at designated timepoints up to Day 15 Urine samples will be collected to determine the Ae of MK-8189
%Dose Excreted in Urine of MK-8189 Predose and at designated timepoints up to Day 15 Urine samples will be collected to determine the %dose of MK-8189
Amount Excreted (Ae) in Feces of MK-8189 Predose and at designated timepoints up to Day 15 Feces samples will be collected to determine the Ae of MK-8189.
%Dose Excreted in Feces of MK-8189 Predose and at designated timepoints up to Day 15 Feces samples will be collected to determine the %dose of MK-8189.
Metabolites in Plasma of MK-8189 Predose and at designated timepoints up to Day 15 Blood samples will be collected to determine the metabolites of MK-8189.
Metabolites in Urine of MK-8189 Predose and at designated timepoints up to Day 15 Urine samples will be collected to determine the metabolites of MK-8189.
Metabolites in Feces of MK-8189 Predose and at designated timepoints up to Day 15 Feces samples will be collected to determine the metabolites of MK-8189.
- Secondary Outcome Measures
Name Time Method Number of Participants Experiencing an Adverse Event (AE) Up to ~ 28 days An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study treatment. For each arm, the number of participants experiencing an AE will be assessed.
Number of Participants Discontinuing Study Treatment due to an AE Up to ~ 28 days An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study treatment. For each arm, the number of participants experiencing an AE will be assessed.
Trial Locations
- Locations (1)
Labcorp Clinical Research Unit Inc. (Site 0001)
🇺🇸Madison, Wisconsin, United States