A Single-Dose Study of the Pharmacokinetics of MK-4618 in Patients With Hepatic Insufficiency (MK-4618-013)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01737684
First received: November 27, 2012
Last updated: July 23, 2013
Last verified: July 2013
  Purpose

This study will investigate the pharmacokinetics of a single oral dose of MK-4618 administered to participants with moderate hepatic insufficiency and healthy participants matched for age, gender, and body mass index (BMI). Participants may be enrolled with mild hepatic insufficiency.


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: A Two-Part, Open-Label, Single-Dose Study to Investigate the Pharmacokinetics of MK-4618 in Patients With Hepatic 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 0 to infinity (AUC0-∞) after a single oral dose of 100 mg of MK-4618 [ Time Frame: Predose to 336 hours post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Apparent clearance (CL/F), calculated as Dose/AUC0-∞, after a single oral dose of 100 mg of MK-4618 [ Time Frame: Predose to 336 hours post-dose ] [ Designated as safety issue: No ]
  • Apparent volume of distribution during the terminal phase (Vd/F) after a single oral dose of 100 mg of MK-4618 [ Time Frame: Predose to 336 hours post-dose ] [ Designated as safety issue: No ]
  • Maximum observed plasma drug concentration (Cmax) after a single oral dose of 100 mg of MK-4618 [ Time Frame: Predose to 336 hours post-dose ] [ Designated as safety issue: No ]
  • Time to maximum observed plasma drug concentration (Tmax) after a single oral dose of 100 mg of MK-4618 [ Time Frame: Predose to 336 hours post-dose ] [ Designated as safety issue: No ]
  • Apparent terminal half-life (t½) after a single oral dose of 100 mg of MK-4618 [ Time Frame: Predose to 336 hours post-dose ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: January 2013
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Moderate Hepatic Insufficiency
Participants with moderate hepatic insufficiency will receive a single 100 mg dose of MK-4618.
Drug: MK-4618
50 mg tablet, oral
Experimental: Healthy
Participants who are healthy will receive a single 100 mg dose of MK-4618.
Drug: MK-4618
50 mg tablet, oral
Experimental: Mild Hepatic Insufficiency
Participants with mild hepatic insufficiency will receive a single 100 mg dose of MK-4618.
Drug: MK-4618
50 mg tablet, oral

Detailed Description:

This study is planned to be conducted in two parts. Part 1 of the study will include participants with moderate hepatic insufficiency and healthy participants. If Part 2 is conducted, Part 2 of the study will include participants with mild hepatic insufficiency.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

For both healthy participants and participants with hepatic insufficiency:

  • Continuous non-smokers who haven't used nicotine-containing products for

at least 3 months prior to study drug administration

  • Body mass index (BMI) ≤39 kg/m^2
  • Good health based on medical history, physical examination, vital signs,

laboratory safety tests, and electrocardiogram (ECG)

  • Females of childbearing potential must be sexually inactive for 14 days

prior to study drug administration and throughout study or use acceptable

birth control method

  • Females of non-childbearing potential must have undergone an acceptable

sterilization procedure at least 6 months prior to Day 1 of study or be

postmenopausal with amenorrhea for at least 1 year prior to Day 1

  • Non-vasectomized males must agree to use a condom with spermicide or

abstain from sexual intercourse during the trial and for 3 months after

study drug administration

For participants with hepatic insufficiency only:

  • Diagnosis of chronic, stable, hepatic insufficiency
  • For Part 1 Participants: Child-Pugh scale range from 7 to 9
  • For Part 2 Participants: Child-Pugh scale range from 5 to 6

Exclusion Criteria

  • History or presence of significant cardiovascular, pulmonary, renal,

hematologic, gastrointestinal, endocrine, immunologic, dermatologic,

neurological disease

  • History or presence of alcoholism or drug abuse within the past 2 years
  • Females who are pregnant or lactating
  • Use of any drugs or substances known to be significant inhibitors or

inducers of cytochrome P3A (CYP3A) enzymes and/or permeability glycoprotein

(P-gp)

  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01737684     History of Changes
Other Study ID Numbers: 4618-013
Study First Received: November 27, 2012
Last Updated: July 23, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Hepatic Insufficiency
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 21, 2014