A Single Dose Study of the Pharmacokinetics of MK-4618 in Participants With Renal Insufficiency (MK-4618-014 AM1)



Status:Completed
Conditions:Overactive Bladder, Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Gastroenterology, Nephrology / Urology
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:July 2012
End Date:November 2012
Contact:Toll Free Number
Phone:1-888-577-8839

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An Open-Label, Single-Dose Study to Investigate the Pharmacokinetics of MK-4618 in Patients With Renal Insufficiency


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


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
We found this trial at
3
sites
2417
mi
from 98109
Neptune, NJ
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2522
mi
from 98109
Tampa, FL
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2525
mi
from 98109
Tampa, FL
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