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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Renal Insufficiency
• Intervention / Treatment: Drug: MK-7145

• Study Type: Interventional
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: April 11, 2013
• First Submitted That Met QC Criteria: April 11, 2013
• First Posted (Estimate): April 15, 2013

Study Record Updates

• Last Update Posted (Estimate): September 24, 2013
• Last Update Submitted That Met QC Criteria: September 23, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency
• Other Study ID Numbers: 7145-018; 2013-000838-35 (EudraCT Number)