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

Merck Sharp & Dohme (MSD)

Status and phase

Withdrawn

Phase 1

Conditions

Renal Insufficiency

Treatments

Drug: MK-7145

Study type

Interventional

Funder types

Industry

Identifiers

NCT01832103

2013-000838-35 (EudraCT Number)

7145-018

Details and patient eligibility

About

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.

Sex

Male

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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