The Pharmacokinetics of MK-7145 Following Single Dose Administration in Participants With Moderate Renal Insufficiency (MK-7145-018)
- Registration Number
- NCT01832103
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Male
- Target Recruitment
- Not specified
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MK-7145 MK-7145 MK-7145 2 mg IR administered as a single oral dose.
- Primary Outcome Measures
Name Time Method Oral Volume of Distribution (V/F) of MK-7145 2 mg IR Following Single Dose Administration Up to 48 Hours Post Dose 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
- Secondary Outcome Measures
Name Time Method Change From Baseline in 24-Hr Urine Natriuresis (UNa0-24) 24 Hours Prior to Dosing (Baseline) and Up to 24 Hours Post Dose