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

Primary Purpose

Renal Insufficiency

Status

Withdrawn

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

MK-7145

About this trial

This is an interventional treatment trial for Renal Insufficiency

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MK-7145

Arm Description

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

Outcomes

Primary Outcome Measures

Area Under the Plasma-Time Curve From 0 to Infinity (AUC0-∞) of MK-7145 2 mg IR Following Single Dose Administration

Maximum Plasma Concentration (Cmax) of MK-7145 2 mg IR Following Single Dose Administration

Time to Maximum Plasma Concentration (Tmax) of MK-7145 2 mg IR Following Single Dose Administration

Apparent Half-Life (t 1/2) of MK-7145 2 mg IR Following Single Dose Administration

Oral Clearance (CL/F) of MK-7145 2 mg IR Following Single Dose Administration

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01832103

First Posted

April 11, 2013

Last Updated

September 23, 2013

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT01832103

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Withdrawn

Study Start Date

August 2013 (undefined)

Primary Completion Date

December 2013 (Anticipated)

Study Completion Date

December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Insufficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MK-7145

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

MK-7145

Primary Outcome Measure Information:

Title

Area Under the Plasma-Time Curve From 0 to Infinity (AUC0-∞) of MK-7145 2 mg IR Following Single Dose Administration

Time Frame

Up to 48 Hours Post Dose

Title

Maximum Plasma Concentration (Cmax) of MK-7145 2 mg IR Following Single Dose Administration

Time Frame

Up to 48 Hours Post Dose

Title

Time to Maximum Plasma Concentration (Tmax) of MK-7145 2 mg IR Following Single Dose Administration

Time Frame

Up to 48 Hours Post Dose

Title

Apparent Half-Life (t 1/2) of MK-7145 2 mg IR Following Single Dose Administration

Time Frame

Up to 48 Hours Post Dose

Title

Oral Clearance (CL/F) of MK-7145 2 mg IR Following Single Dose Administration

Time Frame

Up to 24 Hours Post Dose

Title

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

Time Frame

Up to 48 Hours Post Dose

Secondary Outcome Measure Information:

Title

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

Time Frame

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

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

12. IPD Sharing Statement

Learn more about this trial

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

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