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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Overactive Bladder

Treatments: Drug: Vibegron 100 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01628042

4618-014

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria - Renal Impaired Patients

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

Inclusion Criteria - Healthy Subjects

• Stable baseline health

Exclusion Criteria - Renal Impaired Patients

• 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

Exclusion Criteria - Healthy Subjects

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

Participants With Severe Renal Insufficiency

Experimental group

Description:

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

Treatment:

Drug: Vibegron 100 mg

Participants With Moderate Renal Insufficiency

Experimental group

Description:

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

Treatment:

Drug: Vibegron 100 mg

Participants With Mild Renal Insufficiency

Experimental group

Description:

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

Treatment:

Drug: Vibegron 100 mg

Healthy Matched Control Participants

Experimental group

Description:

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

Treatment:

Drug: Vibegron 100 mg