Pharmacokinetics of MK4305 in Patients With Hepatic Insufficiency

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01043926
First received: January 5, 2010
Last updated: May 26, 2010
Last verified: May 2010
  Purpose

This study will determine whether the plasma concentration-time profile and pharmacokinetics of MK4305 in patients with moderate and mild hepatic insufficiency are similar to those observed in healthy patients.


Condition Intervention Phase
Insomnia
Hepatic Insufficiency
Drug: MK4305
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 Single Dose Study to Investigate the Pharmacokinetics of MK4305 in Patients With Hepatic Insufficiency

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

Primary Outcome Measures:
  • Area under the plasma concentration versus time curve (AUC) in patients with moderate hepatic insufficiency compared to that in healthy subjects [ Time Frame: Up to 144 hours post dose ] [ Designated as safety issue: No ]
  • Area under the plasma concentration versus time curve (AUC) in patients with mild hepatic insufficiency compared to that in healthy subjects [ Time Frame: Up to 144 hours post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability of MK4305 measured by the number of clinical and laboratory adverse events [ Time Frame: Through 14 days after administration of study drug ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: February 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part I: Arm A
Patients with moderate hepatic insufficiency
Drug: MK4305
Single oral dose of 20 mg MK4305 on Day 1 after an overnight fast with water
Experimental: Part I: Arm B
Healthy subjects to match patients with moderate hepatic insufficiency
Drug: MK4305
Single oral dose of 20 mg MK4305 on Day 1 after an overnight fast with water
Experimental: Part II: Arm C
Patients with mild hepatic insufficiency
Drug: MK4305
Single oral dose of 20 mg MK4305 on Day 1 after an overnight fast with water
Experimental: Part II: Arm D
Healthy subjects to match patients with mild hepatic insufficiency
Drug: MK4305
Single oral dose of 20 mg MK4305 on Day 1 after an overnight fast with water

Detailed Description:

Study Design:

If there is no significant difference in the pharmacokinetics of MK4305 between healthy subjects and moderate hepatic insufficiency patients in Part I of the study, then the study will not continue into Part II.

Anticipated Sample Size:

32 (16 in each Part: 8 healthy and 8 patients)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for Hepatic Insufficiency Patients:

  • Females of reproductive potential must have a negative pregnancy test and agree to use two methods of birth control
  • Body Mass Index (BMI) <=35 kg/m prior to start of study
  • Diagnosis of stable hepatic insufficiency
  • Smoking is restricted to <= 10 cigarettes per day

Inclusion Criteria for Healthy Matched Subjects:

  • Females of reproductive potential must have a negative pregnancy test and agree to use two methods of birth control
  • BMI within approximately 20% of that of his/her hepatic subject
  • Healthy subject
  • Subject is matched by race, gender, age (+/- 5 yrs) to his/her hepatic subject enrolled in the study

Exclusion Criteria for Hepatic Insufficiency Patients:

  • Patient is mentally or legally incapacitated
  • History of a clinically significant psychiatric disorder over the last 5 to 10 years
  • Patient has a history of any illness not related to his/her hepatic insufficiency
  • History of a persistent sleep abnormality occurring for three (3) months
  • Patient has a history of stroke, chronic seizures, or major neurological disorder
  • History of clinically significant hematological, immunological, renal, respiratory, or genitourinary abnormalities, uncomplicated kidney stones or childhood asthma
  • History of cancer
  • History of cataplexy
  • Patient is a nursing mother
  • Patient consumes more than 3 servings of alcohol a day
  • Caffeine consumption should be limited to <= then 6 servings a day
  • History of multiple and/or severe allergies
  • Patient is currently using or has history of illegal drug use
  • Patient has a history of any chronic and/or active hepatic disease
  • Patient has traveled across 3 or more time zones
  • Patient works a night shift and is not able to avoid night shift work within 1 week before each treatment visit

Exclusion Criteria for Healthy Matched Subjects:

  • Subject is mentally or legally incapacitated. History of a clinically significant psychiatric disorder over the last 5 to 10 years.
  • Subject has a history of any illness
  • History of a persistent sleep abnormality occurring for three (3) months
  • Subject has a history of stroke, chronic seizures, or major neurological disorder
  • History of clinically significant hematological, immunological, renal, respiratory, or genitourinary abnormalities, uncomplicated kidney stones or childhood asthma
  • History of cancer
  • History of cataplexy
  • Subject is a nursing mother
  • Subject consumes more than 3 servings of alcohol a day
  • Caffeine consumption should be limited to <= then 6 servings a day
  • History of multiple and/or severe allergies
  • Subject is currently using or has history of illegal drug use
  • Subject has a history of any chronic and/or active hepatic disease
  • Subject has traveled across 3 or more time zones
  • Subject works a night shift and is not able to avoid night shift work within 1 week before each treatment visit
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01043926

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT01043926     History of Changes
Other Study ID Numbers: 2010_500, MK4305-017
Study First Received: January 5, 2010
Last Updated: May 26, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Hepatic Insufficiency

Additional relevant MeSH terms:
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 16, 2014