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A Study to Assess Pharmacokinetics of Preladenant in Participants With Chronic Hepatic Impairment (P06513)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01465412
First received: October 28, 2011
Last updated: June 26, 2012
Last verified: June 2012
History of Changes
  Purpose

The purpose of this study is to compare the pharmacokinetics (PK) of preladenant after administration of a single 5 mg oral dose of preladenant in participants with hepatic impairment and healthy volunteers. Part 1 of this study compares healthy volunteers with participants with mild hepatic impairment. Part 2 compares healthy volunteers with participants with moderate hepatic impairment. Healthy volunteers in each part of this study are to be matched with participants with hepatic impairment by race, age, gender, and body mass index (BMI).


Condition Intervention Phase
Chronic Hepatic Impairment
 Drug: Preladenant
 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, Oral Administration, Sequential Two Parts Study to Compare the Pharmacokinetics of SCH 420814 / MK-3814 in Subjects With Mild and Moderate Chronic Hepatic Impairment With Their Respectively Matching Healthy Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Area Under the Plasma Concentration-time curve from time 0 extrapolated to infinity (AUC[0-infinity]) after a single dose of preladenant [ Time Frame: Up to 4 Days ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: November 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mild Hepatic Impaired Participants
Participants with mild chronic liver disease enrolled in Part 1 of study.
 Drug: Preladenant
One 5-mg preladenant tablet, orally, on Day 1.
Other Names:
  • SCH 420814
  • MK-3814
  • Adenosine 2a Antagonist
Active Comparator: Healthy Group to Match Mild Hepatic Impaired Participants
Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 of study.
 Drug: Preladenant
One 5-mg preladenant tablet, orally, on Day 1.
Other Names:
  • SCH 420814
  • MK-3814
  • Adenosine 2a Antagonist
Experimental: Moderate Hepatic Impaired Participants
Participants with moderate chronic liver disease enrolled in Part 2 of study.
 Drug: Preladenant
One 5-mg preladenant tablet, orally, on Day 1.
Other Names:
  • SCH 420814
  • MK-3814
  • Adenosine 2a Antagonist
Active Comparator: Healthy Group to Match Moderate Hepatic Impaired Participants
Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 of study.
 Drug: Preladenant
One 5-mg preladenant tablet, orally, on Day 1.
Other Names:
  • SCH 420814
  • MK-3814
  • Adenosine 2a Antagonist

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria for Healthy Subjects Groups:

  • Must be healthy with normal hepatic function and be free of any clinically significant disease or condition that requires a physician's care and/or would interfere with study evaluations or procedures.

Key Inclusion Criteria for Hepatic Impaired Groups:

  • Must have mild or moderate hepatic impairment.
  • Must have a diagnosis of chronic liver disease for >6 months.
  • Clinical laboratory tests, physical examination, and electrocardiographs must be clinically acceptable to the investigator and sponsor.
  • Must be free, other than chronic liver disease, of significant medical conditions unrelated to their hepatic disorder except for conditions that in the opinion of the investigator may not interfere with the study evaluations, procedures or participation.

Key Exclusion Criteria

  • Must not be on any prohibited medications for entry into the trial.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01465412

Locations
United States, Florida
Call for Information (Investigational Site 0002)
Orlando, Florida, United States, 32809
Sponsors and Collaborators
Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01465412     History of Changes
Other Study ID Numbers: P06513, MK-3814-034
Study First Received: October 28, 2011
Last Updated: June 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck:
Parkinson disease

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 23, 2013