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

• Status: Withdrawn
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

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