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:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01628042
First received: June 22, 2012
Last updated: February 7, 2013
Last verified: February 2013
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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 |
Further study details as provided by Merck:
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
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT01628042 History of Changes |
| Other Study ID Numbers: | 4618-014 |
| Study First Received: | June 22, 2012 |
| Last Updated: | February 7, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Renal Insufficiency Urinary Bladder, Overactive Kidney Diseases Urologic Diseases |
Urinary Bladder Diseases Urological Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013