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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 Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01465412
First received: October 28, 2011
Last updated: March 8, 2016
Last verified: March 2016
  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). The primary hypotheses are that in participants with mild or moderate HI, the area under the concentration-time curve from time 0 extrapolated to time of the last quantifiable concentration (AUC0-t) of preladenant is similar to that observed in matched healthy volunteers, so that the mean ratio of hepatic impaired/healthy is contained within the interval [0.50, 2.00].

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:


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

Primary Outcome Measures:
  • Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Time of the Last Quantifiable Concentration (AUC 0-t) of Preladenant After a Single Dose of Preladenant [ Time Frame: Pre-dose up to 72 hours postdose ] [ Designated as safety issue: No ]
    For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the AUC 0-t of preladenant.

  • Maximum Observed Plasma Concentration (Cmax) of Preladenant After a Single Dose of Preladenant [ Time Frame: Pre-dose up to 72 hours postdose ] [ Designated as safety issue: No ]
    For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the Cmax of preladenant.


Secondary Outcome Measures:
  • AUC 0-t of Preladenant Metabolite SCH 434748 After a Single Dose of Preladenant [ Time Frame: Pre-dose up to 72 hours postdose ] [ Designated as safety issue: No ]
    For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the AUC 0-t of SCH 434748.

  • Cmax of Preladenant Metabolite SCH 434748 After a Single Dose of Preladenant [ Time Frame: Pre-dose up to 72 hours postdose ] [ Designated as safety issue: No ]
    For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the Cmax of SCH 434748.

  • AUC 0-t of Preladenant Metabolite SCH 446637 After a Single Dose of Preladenant [ Time Frame: Pre-dose up to 72 hours postdose ] [ Designated as safety issue: No ]
    For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the AUC 0-t of SCH 446637.

  • Cmax of Preladenant Metabolite SCH 446637 After a Single Dose of Preladenant [ Time Frame: Pre-dose up to 72 hours postdose ] [ Designated as safety issue: No ]
    For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the Cmax of SCH 446637.

  • AUC 0-t of Preladenant Calculated Using Free Drug Concentration After a Single Dose of Preladenant [ Time Frame: Pre-dose up to 72 hours postdose ] [ Designated as safety issue: No ]
    For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the AUC 0-t of preladenant calculated using free drug concentration.

  • Cmax of Preladenant Calculated Using Free Drug Concentration After a Single Dose of Preladenant [ Time Frame: Pre-dose up to 72 hours postdose ] [ Designated as safety issue: No ]
    For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the Cmax of preladenant calculated using free drug concentration.


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 (HI) Part 1
Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
Drug: Preladenant
After at least an 8 hours overnight fast, one 5-mg preladenant tablet, is administered orally, on Day 1.
Other Names:
  • SCH 420814
  • MK-3814
  • Adenosine 2a Antagonist
Active Comparator: Healthy to Match Mild HI Part 1
Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
Drug: Preladenant
After at least an 8 hours overnight fast, one 5-mg preladenant tablet, is administered orally, on Day 1.
Other Names:
  • SCH 420814
  • MK-3814
  • Adenosine 2a Antagonist
Experimental: Moderate HI Part 2
Participants with moderate chronic liver disease enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
Drug: Preladenant
After at least an 8 hours overnight fast, one 5-mg preladenant tablet, is administered orally, on Day 1.
Other Names:
  • SCH 420814
  • MK-3814
  • Adenosine 2a Antagonist
Active Comparator: Healthy to Match Moderate HI Part 2
Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
Drug: Preladenant
After at least an 8 hours overnight fast, one 5-mg preladenant tablet, is administered orally, on Day 1.
Other Names:
  • SCH 420814
  • MK-3814
  • Adenosine 2a Antagonist

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria for Healthy Participants 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
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: NCT01465412

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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01465412     History of Changes
Other Study ID Numbers: P06513  MK-3814-034 
Study First Received: October 28, 2011
Results First Received: March 8, 2016
Last Updated: March 8, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Parkinson disease

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on December 09, 2016