A Single Dose Study of the Pharmacokinetics of Vibegron (MK-4618) in Participants With Renal Insufficiency (MK-4618-014)

NCT ID: NCT01628042

Last Updated: 2018-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-16
• Study Completion Date: 2013-01-25

Brief Summary

This study will investigate the impact of impaired renal function on the plasma pharmacokinetics of vibegron (MK-4618) to guide use of vibegron in clinical trials in participants with overactive bladder and to guide recommendations on potential dosing adjustments for individuals with varying degrees of renal impairment.

Conditions

Overactive Bladder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Participants With Severe Renal Insufficiency

Participants will receive a single oral dose of vibegron 100 mg on Day 1.

Group Type: EXPERIMENTAL

Vibegron 100 mg

Intervention Type: DRUG

Vibegron tablets, orally, on Day 1

Participants With Moderate Renal Insufficiency

Participants will receive a single oral dose of vibegron 100 mg on Day 1.

Group Type: EXPERIMENTAL

Vibegron 100 mg

Intervention Type: DRUG

Vibegron tablets, orally, on Day 1

Participants With Mild Renal Insufficiency

Participants will receive a single oral dose of vibegron 100 mg on Day 1.

Group Type: EXPERIMENTAL

Vibegron 100 mg

Intervention Type: DRUG

Vibegron tablets, orally, on Day 1

Healthy Matched Control Participants

Participants receive a single oral dose of vibegron 100 mg on Day 1.

Group Type: EXPERIMENTAL

Vibegron 100 mg

Intervention Type: DRUG

Vibegron tablets, orally, on Day 1

Interventions

Vibegron 100 mg

Vibegron tablets, orally, on Day 1

Intervention Type: DRUG

Other Intervention Names

MK-4618

Eligibility Criteria

Inclusion Criteria

• Body mass index (BMI) ≤40 kg/m^2
• Clinical diagnosis of renal insufficiency
• Stable baseline health

• Stable baseline health

Exclusion Criteria

• History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, immunological, respiratory, or genitourinary disease
• History of recent stroke, chronic seizures, or major neurological disorder
• Demonstrated or suspected renal artery stenosis
• Renal transplant or nephrectomy
• History of cancer excepting certain skin or cervical cancers or cancers that were successfully treated 10 or more years prior to screening
• History of significant multiple and/or severe allergies (including latex allergy), or anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
• Unable to refrain from or anticipates the use of any medication including prescription and non-prescription drugs or herbal remedies beginning approximately 2 weeks prior to administration of study drug, throughout the study, and until the post study visit
• Unable to avoid taking diuretics within 4 hours prior to dosing and 4 hours post dosing; must be on a stable dose for at least approximately 2 weeks (or 5 half-lives of the compound, whichever is longer)
• Unwilling to refrain from consuming any food or drink/beverage containing grapefruit or grapefruit juice, apple or orange juice, vegetables from the mustard green family (e.g., kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, mustard), and charbroiled meats 2 weeks prior to dosing until the post-study visit
• Consumption of excessive amounts of alcohol, defined as greater than 3 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer [284 mL/10 ounces], wine [125 mL/4 ounces], or distilled spirits [25 mL/1 ounce]) per day
• Consumption of excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, or other caffeinated beverages per day
• Major surgery, donation or loss of 1 unit of blood (approximately 500 mL) within 4 weeks prior to administration of study drug
• Plasma donation within 7 days prior to administration of study drug
• Current regular user (including "recreational use") of any illicit drugs or has a history of drug (including alcohol) abuse within approximately 12 months
• Nursing mother
• Participation in another investigational study within 4 weeks of study enrollment

• History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
• History of stroke, chronic seizures, or major neurological disorder
• History of cancer excepting certain skin or cervical cancers or cancers that were successfully treated 10 or more years prior to screening
• History of significant multiple and/or severe allergies (including latex allergy), or anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
• Unable to refrain from or anticipates the use of any medication including prescription and non-prescription drugs or herbal remedies beginning approximately 2 weeks prior to administration of the dose of study drug, throughout the study, until the post study visit
• Unwilling to refrain from consuming any food or drink/beverage containing grapefruit or grapefruit juice, apple or orange juice, vegetables from the mustard green family (e.g., kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, mustard), and charbroiled meats 2 weeks prior to dosing until the post study visit
• Consumption of excessive amounts of alcohol, defined as greater than 3 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer [284 mL/10 ounces], wine [125 mL/4 ounces], or distilled spirits [25 mL/1 ounce]) per day
• Consumption of excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, or other caffeinated beverages per day
• Major surgery, donation or loss of 1 unit of blood (approximately 500 mL) within 4 weeks prior to administration of study drug
• Plasma donation within 7 days prior to administration of study drug
• Current regular user (including "recreational use") of any illicit drugs or has a history of drug (including alcohol) abuse within approximately 12 months
• Nursing mother
• Participation in another investigational study within 4 weeks of study enrollment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Countries

United States

Other Identifiers

4618-014

Identifier Type: -

Identifier Source: org_study_id