The Pharmacokinetics of MK-7145 Following Single Dose Adm... | NCT01832103

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

NCT01832103

Sponsor

Merck Sharp & Dohme LLC

Status

Withdrawn

Last Update Posted

Sep 24, 2013Estimated

Enrollment

0Actual

Phase

Phase 1

Conditions

Renal Insufficiency

Interventions

MK-7145

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2013-000838-35	EudraCT Number

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2013

Primary Completion Date

Dec 2013Estimated

Completion Date

Dec 2013Estimated

First Submitted Date

Apr 11, 2013

First Submission Date that Met QC Criteria

Apr 11, 2013

First Posted Date

Apr 15, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 23, 2013

Last Update Posted Date

Sep 24, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
MK-7145	Experimental	MK-7145 2 mg IR administered as a single oral dose.	Drug: MK-7145

Name	Type	Description	Arm Group Labels	Other Names
MK-7145	Drug		MK-7145

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications