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

Renal Insufficiency Clinical Trial

Official title:

A Phase I Study to Evaluate the Pharmacokinetics of MK-7145 Following Single Dose Administration in Patients With Moderate Renal Insufficiency

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01832103
• Other study ID #: 7145-018
• Secondary ID: 2013-000838-35
• Status: Withdrawn
• Phase: Phase 1
• First received: April 11, 2013
• Last updated: September 23, 2013
• Start date: August 2013
• Est. completion date: December 2013

Study information

• Verified date: September 2013
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Moldova: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Insufficiency

Intervention

Drug:
• MK-7145

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Plasma-Time Curve From 0 to Infinity (AUC0-8) of MK-7145 2 mg IR Following Single Dose Administration		Up to 48 Hours Post Dose	No
Primary	Maximum Plasma Concentration (Cmax) of MK-7145 2 mg IR Following Single Dose Administration		Up to 48 Hours Post Dose	No
Primary	Time to Maximum Plasma Concentration (Tmax) of MK-7145 2 mg IR Following Single Dose Administration		Up to 48 Hours Post Dose	No
Primary	Apparent Half-Life (t 1/2) of MK-7145 2 mg IR Following Single Dose Administration		Up to 48 Hours Post Dose	No
Primary	Oral Clearance (CL/F) of MK-7145 2 mg IR Following Single Dose Administration		Up to 24 Hours Post Dose	No
Primary	Oral Volume of Distribution (V/F) of MK-7145 2 mg IR Following Single Dose Administration		Up to 48 Hours Post Dose	No
Secondary	Change From Baseline in 24-Hr Urine Natriuresis (UNa0-24)		24 Hours Prior to Dosing (Baseline) and Up to 24 Hours Post Dose	No