Clinical trial NCT06687759: A Study of MK-1084 Human Absorption, Distribution, Metabolism, and Excretion in Healthy Adult Participants (MK-1084-006)
Official title: A Phase 1 Study to Evaluate the Absorption, Distribution, Metabolism, and Excretion of [14C]MK-1084 in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-11-14
Enrollment: 8
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-1084 in a healthy person's body over time and how it is cleared from the body.


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,vital signs measurements, and electrocardiogram (ECG)s performed before randomization.
* Has a body mass index (BMI) 18 to 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 Time 0 to Infinity (AUC0-Inf) of plasma MK-1084
timeFrame: Predose and at designated timepoints up to Day 15
measure: Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of plasma MK-1084
timeFrame: Predose and at designated timepoints up to Day 15
measure: Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of plasma MK-1084
timeFrame: Predose and at designated timepoints up to Day 15
measure: Maximum Concentration (Cmax) of plasma MK-1084
timeFrame: Predose and at designated timepoints up to Day 15
measure: Concentration at 24 hours postdose (C24) of plasma MK-1084
timeFrame: Predose and at designated timepoints up to Day 15
measure: Time to Reach Maximum Concentration (Tmax) of plasma MK-1084
timeFrame: Predose and at designated timepoints up to Day 15
measure: Apparent Half Life (t½) of plasma MK-1084
timeFrame: Predose and at designated timepoints up to Day 15
measure: Apparent Total Clearance (CL/F) of plasma MK-1084
timeFrame: Predose and at designated timepoints up to Day 15
measure: Apparent Volume of Distribution during the Terminal Elimination Phase (Vz/F) of plasma MK-1084
timeFrame: Predose and at designated timepoints up to Day 15
measure: AUC0-inf/Total Radioactivity Ratio of plasma MK-1084
timeFrame: Predose and at designated timepoints up to Day 15
measure: Amount Excreted in the Urine (Aeu) of MK-1084
timeFrame: Predose and at designated timepoints up to Day 15
measure: Cumulative Aeu of MK-1084
timeFrame: Predose and at designated timepoints up to Day 15
measure: Percentage Excreted in the Urine (feu) of MK-1084
timeFrame: Predose and at designated timepoints up to Day 15
measure: Cumulative feu of MK-1084
timeFrame: Predose and at designated timepoints up to Day 15
measure: Amount Excreted in the Feces (Aef) of MK-1084
timeFrame: Predose and at designated timepoints up to Day 15
measure: Cumulative Aef of MK-1084
timeFrame: Predose and at designated timepoints up to Day 15
measure: Percentage Excreted in the Feces (fef) of MK-1084
timeFrame: Predose and at designated timepoints up to Day 15
measure: Cumulative fef of MK-1084
timeFrame: Predose and at designated timepoints up to Day 15
measure: Metabolites in Plasma of MK-1084
timeFrame: Predose and at designated timepoints up to Day 15
measure: Metabolites in Urine of MK-1084
timeFrame: Predose and at designated timepoints up to Day 15
measure: Metabolites in Feces of MK-1084
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: Fortea CRU Madison (Site 0001)
state: Wisconsin
Study officials:
References: