A Single Dose Study of the Pharmacokinetics of Vibegron (MK-4618) in Participants With Renal Insufficiency (MK-4618-014)
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive; Renal Insufficiency
Intervention: Vibegron 100 mg
Intervention description: Vibegron tablets, orally, on Day 1
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility 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