Phase 1
Completed N=32
A Single Dose Study of the Pharmacokinetics of Vibegron (MK-4618) in Participants With Renal Insufficiency (MK-4618-014)
Source: ClinicalTrials.gov NCT01628042 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcomePrimary: Area Under the Concentration-time Curve From 0 to Infinity (AUC0-∞) After a Single Oral Dose of Vibegron 100 mg — 6337.17; 7137.53; 5156.07; 3466.04 nM•hr
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-time Curve From 0 to Infinity (AUC0-∞) After a Single Oral Dose of Vibegron 100 mg |
6337.17; 7137.53; 5156.07; 3466.04 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) After a Single Oral Dose of Vibegron 100 mg |
342.83; 404.50; 473.01; 240.80 | — |
| PRIMARY Apparent Total Body Clearance (CL/F) After a Single Oral Dose of Vibegron 100 mg |
35.5; 31.5; 43.6; 64.9 | — |
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
Data sourced from ClinicalTrials.gov (NCT01628042). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.