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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01628042
First received: June 22, 2012
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Overactive Bladder
Drug: MK-4618
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Single-Dose Study to Investigate the Pharmacokinetics of MK-4618 in Patients With Renal Insufficiency

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Area under the concentration time curve from Hour 0 to infinity (AUC0-∞) after a single oral dose of MK-4618 [ Time Frame: Predose to 336 hours post-dose ] [ Designated as safety issue: No ]
  • Maximum plasma concentration (Cmax) after a single oral dose of MK-4618 [ Time Frame: Predose to 336 hours post-dose ] [ Designated as safety issue: No ]
  • Total body clearance from plasma (CL/F) after a single oral dose of MK-4618 [ Time Frame: Predose to 336 hours post-dose ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: July 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Panel A (severe renal impairment) Drug: MK-4618
MK-4618 tablets, orally, on Day 1
Experimental: Panel B (moderate renal impairment) Drug: MK-4618
MK-4618 tablets, orally, on Day 1
Experimental: Panel C (mild renal impairment) Drug: MK-4618
MK-4618 tablets, orally, on Day 1
Experimental: Panel D (healthy participants) Drug: MK-4618
MK-4618 tablets, orally, on Day 1

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01628042     History of Changes
Other Study ID Numbers: 4618-014
Study First Received: June 22, 2012
Last Updated: January 30, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Renal Insufficiency
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Kidney Diseases

ClinicalTrials.gov processed this record on September 18, 2014