A Study of MK-1084 Human Absorption, Distribution, Metabolism, and Excretion in Healthy Adult Participants (MK-1084-006)
- Registration Number
- NCT06687759
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this study is to learn what happens to MK-1084 in a healthy person's body over time and how it is cleared from the body.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 8
Key inclusion criteria include but are not limited to the following:
- Is in good health based on medical history, physical examination,vital signs measurements, and electrocardiogram (ECG)s performed before randomization.
- Has a body mass index (BMI) 18 to 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-1084 [14C]MK-1084 Participants receive single oral dose of MK-1084 on Day 1.
- Primary Outcome Measures
Name Time Method Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of plasma MK-1084 Predose and at designated timepoints up to Day 15 Bood samples will be collected to determine the AUC0-inf of MK-1084 in plasma.
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of plasma MK-1084 Predose and at designated timepoints up to Day 15 Blood samples will be collected to determine the AUC0-last of MK-1084 in plasma.
Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of plasma MK-1084 Predose and at designated timepoints up to Day 15 Blood samples will be collected to determine the AUC0-24 of plasma MK-1084 in plasma.
Maximum Concentration (Cmax) of plasma MK-1084 Predose and at designated timepoints up to Day 15 Blood samples will be collected to determine the Cmax of MK-1084 in plasma.
Concentration at 24 hours postdose (C24) of plasma MK-1084 Predose and at designated timepoints up to Day 15 Blood samples will be collected to determine the C24 of MK-1084 in plasma.
Time to Reach Maximum Concentration (Tmax) of plasma MK-1084 Predose and at designated timepoints up to Day 15 Blood samples will be collected to determine the Tmax of MK-1084 in plasma.
Apparent Half Life (t½) of plasma MK-1084 Predose and at designated timepoints up to Day 15 Blood samples will be collected to determine the t1/2 of MK-1084 in plasma.
Apparent Total Clearance (CL/F) of plasma MK-1084 Predose and at designated timepoints up to Day 15 Blood samples will be collected to determine the CL/F of MK-1084 in plasma.
Apparent Volume of Distribution during the Terminal Elimination Phase (Vz/F) of plasma MK-1084 Predose and at designated timepoints up to Day 15 Blood samples will be collected to determine the Vz/F of MK-1084 in plasma.
AUC0-inf/Total Radioactivity Ratio of plasma MK-1084 Predose and at designated timepoints up to Day 15 Blood samples will be collected to determine the AUC0-inf/Total Radioactivity Ratio of MK-1084 in plasma.
Amount Excreted in the Urine (Aeu) of MK-1084 Predose and at designated timepoints up to Day 15 Urine samples will be collected to determine the Aeu of MK-1084
Cumulative Aeu of MK-1084 Predose and at designated timepoints up to Day 15 Urine samples will be collected to determine the cumulative Ae of MK-1084.
Percentage Excreted in the Urine (feu) of MK-1084 Predose and at designated timepoints up to Day 15 Urine samples will be collected to determine the feu of MK-1084.
Cumulative feu of MK-1084 Predose and at designated timepoints up to Day 15 Urine samples will be collected to determine the cumulative feu of MK-1084.
Amount Excreted in the Feces (Aef) of MK-1084 Predose and at designated timepoints up to Day 15 Feces samples will be collected to determine the Aef of MK-1084.
Metabolites in Plasma of MK-1084 Predose and at designated timepoints up to Day 15 Blood samples will be collected to determine the metabolites of MK-1084.
Cumulative Aef of MK-1084 Predose and at designated timepoints up to Day 15 Feces samples will be collected to determine the cumulative Aef of MK-1084.
Percentage Excreted in the Feces (fef) of MK-1084 Predose and at designated timepoints up to Day 15 Feces samples will be collected to determine the fef of MK-1084.
Cumulative fef of MK-1084 Predose and at designated timepoints up to Day 15 Feces samples will be collected to determine the cumulative fef of MK-1084.
Metabolites in Urine of MK-1084 Predose and at designated timepoints up to Day 15 Urine samples will be collected to determine the metabolites of MK-1084.
Metabolites in Feces of MK-1084 Predose and at designated timepoints up to Day 15 Feces samples will be collected to determine the metabolites of MK-1084.
- 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)
Fortea CRU Madison (Site 0001)
🇺🇸Madison, Wisconsin, United States