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

NCT ID: NCT01832103

Last Updated: 2013-09-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2013-12-31

Brief Summary

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.

Conditions

Renal Insufficiency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MK-7145

MK-7145 2 mg IR administered as a single oral dose.

Group Type: EXPERIMENTAL

MK-7145

Intervention Type: DRUG

Interventions

MK-7145

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2013-000838-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

7145-018

Identifier Type: -

Identifier Source: org_study_id