The Pharmacokinetics of MK-7145 Following Single Dose Administration in Participants With Moderate Renal Insufficiency (MK-7145-018)

Study Overview
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Brief Summary
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The primary purpose of this study is to obtain a preliminary pharmacokinetic profile of MK-7145 2 mg immediate release (IR) following single-dose administration in male participants with moderate renal insufficiency. In addition, the study will evaluate the pharmacodynamic effect of a single dose of MK-7145 2 mg IR on 24-hour net natriuresis in male participants with moderate renal insufficiency.

Official Title
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A Phase I Study to Evaluate the Pharmacokinetics of MK-7145 Following Single Dose Administration in Patients With Moderate Renal Insufficiency

Conditions
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Renal Insufficiency

Intervention / Treatment
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* Drug: MK-7145


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index (BMI) 18 to 35 kg/m^2 Nonsmoker and/or have not used nicotine or nicotine-containing products for at least 3 months prior to enrollment Estimated glomerular filtration rate (eGFR) 30 to 60 mL/min/1.73 m^2 Exclusion Criteria: History of stroke, chronic seizures, or major neurological disorder Ongoing, clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, respiratory, or genitourinary abnormalities or diseases Systolic blood pressure (SBP) ≤95 mmHg or >160 mmHg, or diastolic blood pressure (DBP) ≤45 mmHg or >95 mmHg History of neoplastic disease except for adequately treated non-melanomatous skin carcinoma Unable to refrain from, or anticipates the use of, strong/moderate cytochrome P450 3A4 (CYP3A4) inhibitors Consumes excessive amounts of alcohol, defined as greater than 3 glasses of alcoholic beverages, wine, or distilled spirits per day Consumes excessive amounts of caffeine, defined as greater than 6 servings of coffee, tea, cola, or other caffeinated beverages per day Had major surgery or donated blood within 8 weeks prior to enrollment Has participated in another investigational study within 4 weeks prior History of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerance to prescription or nonprescription drugs or food Currently a regular user of illicit drugs, or has a history of drug (including alcohol) abuse within approximately 6 months Has active or has a history of nephrolithiasis Has had a kidney removed or has a functioning renal transplant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MK-7145<br>MK-7145 2 mg IR administered as a single oral dose. | Drug: MK-7145<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Plasma-Time Curve From 0 to Infinity (AUC0-∞) of MK-7145 2 mg IR Following Single Dose Administration |  | Up to 48 Hours Post Dose | 
| Maximum Plasma Concentration (Cmax) of MK-7145 2 mg IR Following Single Dose Administration |  | Up to 48 Hours Post Dose | 
| Time to Maximum Plasma Concentration (Tmax) of MK-7145 2 mg IR Following Single Dose Administration |  | Up to 48 Hours Post Dose | 
| Apparent Half-Life (t 1/2) of MK-7145 2 mg IR Following Single Dose Administration |  | Up to 48 Hours Post Dose | 
| Oral Clearance (CL/F) of MK-7145 2 mg IR Following Single Dose Administration |  | Up to 24 Hours Post Dose | 
| Oral Volume of Distribution (V/F) of MK-7145 2 mg IR Following Single Dose Administration |  | Up to 48 Hours Post Dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in 24-Hr Urine Natriuresis (UNa0-24) |  | 24 Hours Prior to Dosing (Baseline) and Up to 24 Hours Post Dose |