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A Study to Assess Pharmacokinetics (PK) of Preladenant in Participants With Chronic Renal Impairment (CRI) (P06512)

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Preladenant
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Has a body mass index (BMI) between 19 to 34 kg/m^2, inclusive
  • Has mild to severe CRI and not on dialysis (Participants with normal renal function are to be matched to subjects with renal impairment)
  • Clinical laboratory tests, electrocardiogram, and vital signs within normal ranges
  • Free of any clinically significant disease that would interfere with the study evaluations (except related to his/her renal disease and comorbid conditions)

Exclusion Criteria:

  • Females who are pregnant, intend to become pregnant (within 3 months of ending the study), or are nursing/breastfeeding
  • Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug
  • Had a renal transplant or are on dialysis
  • Has a history of any infectious disease within 4 weeks
  • Is positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV)
  • Has donated blood or had a blood transfusions in the past 60 days
  • Has demonstrated allergic reactions (eg, food, drug, atopic reactions or asthmatic episodes) which could interfere with their ability to participate in the trial
  • Has a history of malignancy
  • Has evidence of suicidality or is at risk for self-harm or harm to others

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Part 1: Severe Renal Impairment

    Part 2: Moderate Renal Impairment

    Part 2: Mild Renal Impairment

    Part 1: Normal Renal Function

    Part 2: Normal Renal Function

    Arm Description

    Participants with severe CRI, defined as creatinine clearance of <30 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally

    Participants with moderate CRI defined as creatinine clearance of ≥30 and <50 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally

    Participants with mild CRI, defined as creatinine clearance of ≥50 and ≤80 mL/min/1.73m^2, were treated with a single tablet of 5 mg preladenant, administered orally

    Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally

    Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally

    Outcomes

    Primary Outcome Measures

    Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) After Single Dosing With Preladenant for Participants With Severe CRI Versus Healthy Matched Controls
    Blood samples were taken at the following timepoints: pre-dose, 0.25, 0.50, 0.75, 1, 2, 4, 6, 12, 16, 24, 30, 36 and 48 hours postdose in order to determine the AUC0-∞ of preladenant
    AUC0-∞ After Single Dosing With Preladenant for Participants With Moderate CRI Versus Healthy Matched Controls
    Blood samples were taken at the following timepoints: pre-dose, 0.25, 0.50, 0.75, 1, 2, 4, 6, 12, 16, 24, 30, 36 and 48 hours postdose in order to determine the AUC0-∞ of preladenant
    AUC0-∞ After Single Dosing With Preladenant for Participants With Mild CRI Versus Healthy Matched Controls
    Blood samples were taken at the following timepoints: pre-dose, 0.25, 0.50, 0.75, 1, 2, 4, 6, 12, 16, 24, 30, 36 and 48 hours postdose in order to determine the AUC0-∞ of preladenant

    Secondary Outcome Measures

    Full Information

    First Posted
    March 24, 2011
    Last Updated
    September 1, 2018
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01323855
    Brief Title
    A Study to Assess Pharmacokinetics (PK) of Preladenant in Participants With Chronic Renal Impairment (CRI) (P06512)
    Official Title
    A Study to Assess Pharmacokinetics of Preladenant in Subjects With Chronic Renal Impairment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    March 28, 2011 (Actual)
    Primary Completion Date
    November 29, 2011 (Actual)
    Study Completion Date
    November 29, 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a two part study to compare the PK of preladenant administered to participants with CRI to the PK of preladenant administered to healthy participants. Part 1 will compare the PK of participants with severe CRI to healthy participants. Part 2 will compare the PK of participants with moderate CRI and participants with mild CRI to healthy participants. The primary hypotheses are that the plasma area under the concentration-time curve from time 0 to infinity after single dosing (AUC0-∞) of preladenant in participants with either severe, moderate or mild CRI is similar to that of matched healthy participants.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    46 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Part 1: Severe Renal Impairment
    Arm Type
    Experimental
    Arm Description
    Participants with severe CRI, defined as creatinine clearance of <30 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
    Arm Title
    Part 2: Moderate Renal Impairment
    Arm Type
    Experimental
    Arm Description
    Participants with moderate CRI defined as creatinine clearance of ≥30 and <50 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
    Arm Title
    Part 2: Mild Renal Impairment
    Arm Type
    Experimental
    Arm Description
    Participants with mild CRI, defined as creatinine clearance of ≥50 and ≤80 mL/min/1.73m^2, were treated with a single tablet of 5 mg preladenant, administered orally
    Arm Title
    Part 1: Normal Renal Function
    Arm Type
    Experimental
    Arm Description
    Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
    Arm Title
    Part 2: Normal Renal Function
    Arm Type
    Experimental
    Arm Description
    Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
    Intervention Type
    Drug
    Intervention Name(s)
    Preladenant
    Other Intervention Name(s)
    SCH 420814
    Intervention Description
    After an overnight fast, a single 5 mg dose, (1 x 5 mg tablet) was administered orally
    Primary Outcome Measure Information:
    Title
    Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) After Single Dosing With Preladenant for Participants With Severe CRI Versus Healthy Matched Controls
    Description
    Blood samples were taken at the following timepoints: pre-dose, 0.25, 0.50, 0.75, 1, 2, 4, 6, 12, 16, 24, 30, 36 and 48 hours postdose in order to determine the AUC0-∞ of preladenant
    Time Frame
    Pre-dose to 48 hours post-dose
    Title
    AUC0-∞ After Single Dosing With Preladenant for Participants With Moderate CRI Versus Healthy Matched Controls
    Description
    Blood samples were taken at the following timepoints: pre-dose, 0.25, 0.50, 0.75, 1, 2, 4, 6, 12, 16, 24, 30, 36 and 48 hours postdose in order to determine the AUC0-∞ of preladenant
    Time Frame
    Pre-dose to 48 hours post-dose
    Title
    AUC0-∞ After Single Dosing With Preladenant for Participants With Mild CRI Versus Healthy Matched Controls
    Description
    Blood samples were taken at the following timepoints: pre-dose, 0.25, 0.50, 0.75, 1, 2, 4, 6, 12, 16, 24, 30, 36 and 48 hours postdose in order to determine the AUC0-∞ of preladenant
    Time Frame
    Pre-dose to 48 hours post-dose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Has a body mass index (BMI) between 19 to 34 kg/m^2, inclusive Has mild to severe CRI and not on dialysis (Participants with normal renal function are to be matched to subjects with renal impairment) Clinical laboratory tests, electrocardiogram, and vital signs within normal ranges Free of any clinically significant disease that would interfere with the study evaluations (except related to his/her renal disease and comorbid conditions) Exclusion Criteria: Females who are pregnant, intend to become pregnant (within 3 months of ending the study), or are nursing/breastfeeding Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug Had a renal transplant or are on dialysis Has a history of any infectious disease within 4 weeks Is positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV) Has donated blood or had a blood transfusions in the past 60 days Has demonstrated allergic reactions (eg, food, drug, atopic reactions or asthmatic episodes) which could interfere with their ability to participate in the trial Has a history of malignancy Has evidence of suicidality or is at risk for self-harm or harm to others
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php

    Learn more about this trial

    A Study to Assess Pharmacokinetics (PK) of Preladenant in Participants With Chronic Renal Impairment (CRI) (P06512)

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