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Withdrawn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
Sponsored by
About this trial
This is an interventional treatment trial for Renal Insufficiency
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
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
No
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
No
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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