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

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

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01832103

Enrollment

Registered

2013-04-15

Start date

2013-08-31

Completion date

2013-12-31

Last updated

2013-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Insufficiency

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.

Interventions

DRUGMK-7145

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Time to Maximum Plasma Concentration (Tmax) 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
Oral Volume of Distribution (V/F) 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

Measure	Time frame
Change From Baseline in 24-Hr Urine Natriuresis (UNa0-24)	24 Hours Prior to Dosing (Baseline) and Up to 24 Hours Post Dose

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026