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
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.

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 July 26, 2014