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

NCT01832103 | Withdrawn Phase 1

• 2 other identifiers: 7145-0182013-000838-35
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Renal Insufficiency

Outcome Measures

Primary Outcomes (6)

• 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

• Time to Maximum Plasma Concentration (Tmax) 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

• Oral Volume of Distribution (V/F) of MK-7145 2 mg IR Following Single Dose Administration

  Up to 48 Hours Post Dose

Secondary Outcomes (1)

• Change From Baseline in 24-Hr Urine Natriuresis (UNa0-24)

  24 Hours Prior to Dosing (Baseline) and Up to 24 Hours Post Dose

Study Arms (1)

MK-7145

EXPERIMENTAL

MK-7145 2 mg IR administered as a single oral dose.

Drug: MK-7145

Interventions

MK-7145 DRUG

MK-7145

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Renal Insufficiency

Interventions

MK-7145

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2013
• First Posted: April 15, 2013
• Study Start: August 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 24, 2013

Record last verified: 2013-09