Status:
WITHDRAWN
The Pharmacokinetics of MK-7145 Following Single Dose Administration in Participants With Moderate Renal Insufficiency (MK-7145-018)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Renal Insufficiency
Eligibility:
MALE
18-75 years
Phase:
PHASE1
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 rena...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01832103
Start Date
August 1 2013
End Date
December 1 2013
Last Update
September 24 2013
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