Clinical trial NCT01832103: The Pharmacokinetics of MK-7145 Following Single Dose Administration in Participants With Moderate Renal Insufficiency (MK-7145-018)
Official title: A Phase I Study to Evaluate the Pharmacokinetics of MK-7145 Following Single Dose Administration in Patients With Moderate Renal Insufficiency
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Renal Insufficiency
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2013-04-15
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Area Under the Plasma-Time Curve From 0 to Infinity (AUC0-∞) of MK-7145 2 mg IR Following Single Dose Administration
timeFrame: Up to 48 Hours Post Dose
measure: Maximum Plasma Concentration (Cmax) of MK-7145 2 mg IR Following Single Dose Administration
timeFrame: Up to 48 Hours Post Dose
measure: Time to Maximum Plasma Concentration (Tmax) of MK-7145 2 mg IR Following Single Dose Administration
timeFrame: Up to 48 Hours Post Dose
measure: Apparent Half-Life (t 1/2) of MK-7145 2 mg IR Following Single Dose Administration
timeFrame: Up to 48 Hours Post Dose
measure: Oral Clearance (CL/F) of MK-7145 2 mg IR Following Single Dose Administration
timeFrame: Up to 24 Hours Post Dose
measure: Oral Volume of Distribution (V/F) of MK-7145 2 mg IR Following Single Dose Administration
timeFrame: Up to 48 Hours Post Dose
Secondary outcomes:
measure: Change From Baseline in 24-Hr Urine Natriuresis (UNa0-24)
timeFrame: 24 Hours Prior to Dosing (Baseline) and Up to 24 Hours Post Dose
Other outcomes:
Locations:
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