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A Study of Extended-release (ER) Niacin/Laropiprant in Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0524A-158)

Primary Purpose

Hypercholesterolemia, Familial, Heterozygous Familial Hypercholesterolemia

Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
MK-0524A
MK-0524A
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia, Familial

Eligibility Criteria

10 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Post-pubescent adolescent age 10 to 16 with heterozygous familial hypercholesterolemia
  • Agree to use (and/or have their partner use) acceptable methods of birth control beginning at the prestudy visit until at least 2 weeks after dosing of study drug
  • Height and weight fall between the 10th and 95th percentile for age with a minimum body weight of 23 kg
  • Receiving appropriate medical care for hypercholesterolemia, such as a statin or other lipid-modifying therapy.

Exclusion Criteria:

  • History of psychiatric or personality disorders that may affect the patient's ability to participate
  • History of stroke, chronic seizures, or major neurological disorder
  • History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases (excluding lipid abnormalities)
  • Poorly controlled or recently diagnosed Type 1 or Type 2 diabetes mellitus
  • History of neoplastic disease within previous 5 years
  • Consumes alcohol or excessive amounts of products that contain caffeine (e.g. cola)
  • Has had major surgery, donated and/or received blood within previous 8 weeks
  • Participated in another investigational study within previous 4 weeks
  • History of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
  • Positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV)
  • Cannot swallow large tablets
  • Pregnant or breastfeeding

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    MK-0524A 1 g/20 mg (Panel A)

    MK-0524A 2 g/40 mg (Panel B)

    Arm Description

    Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg

    Single oral dose of 2 tablets of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg

    Outcomes

    Primary Outcome Measures

    Plasma Area Under the Concentration Curve From 0 to Infinity (AUC0-∞) of Laropiprant
    Plasma Maximum Concentration (Cmax) of Laropiprant
    Total Urinary Excretion of Niacin and Niacin Metabolites
    Plasma Cmax of Nicotinuric Acid (NUA)

    Secondary Outcome Measures

    Full Information

    First Posted
    April 20, 2012
    Last Updated
    November 2, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01583647
    Brief Title
    A Study of Extended-release (ER) Niacin/Laropiprant in Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0524A-158)
    Official Title
    A Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ER Niacin/Laropiprant in Adolescents With Heterozygous Familial Hypercholesterolemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Terminated
    Why Stopped
    In HPS2-THRIVE, MK-0524A did not meet the primary efficacy objective and there was a significant increase in incidence of some types of non-fatal SAEs.
    Study Start Date
    June 2012 (undefined)
    Primary Completion Date
    December 2012 (Actual)
    Study Completion Date
    December 2012 (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
    The purpose of this study is to determine the pharmacokinetics of laropiprant following administration of a single dose of 1 (Panel A) and 2 (Panel B) combination tablets of MK-0524A in adolescents with heterozygous familial hypercholesterolemia.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypercholesterolemia, Familial, Heterozygous Familial Hypercholesterolemia

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    MK-0524A 1 g/20 mg (Panel A)
    Arm Type
    Experimental
    Arm Description
    Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
    Arm Title
    MK-0524A 2 g/40 mg (Panel B)
    Arm Type
    Experimental
    Arm Description
    Single oral dose of 2 tablets of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
    Intervention Type
    Drug
    Intervention Name(s)
    MK-0524A
    Other Intervention Name(s)
    Extended-release (ER) Niacin/Laropiprant
    Intervention Description
    1 tablet of MK-0524A (1g ER niacin/20mg laropripant) orally
    Intervention Type
    Drug
    Intervention Name(s)
    MK-0524A
    Other Intervention Name(s)
    Extended-release (ER) Niacin/Laropiprant
    Intervention Description
    2 tablets of MK-0524A (1g ER niacin/20mg laropripant) orally
    Primary Outcome Measure Information:
    Title
    Plasma Area Under the Concentration Curve From 0 to Infinity (AUC0-∞) of Laropiprant
    Time Frame
    Predose Day 1 up to 24 hours postdose
    Title
    Plasma Maximum Concentration (Cmax) of Laropiprant
    Time Frame
    Predose on Day 1 up to 48 hours postdose
    Title
    Total Urinary Excretion of Niacin and Niacin Metabolites
    Time Frame
    Predose on Day 1 up to 72 hours postdose
    Title
    Plasma Cmax of Nicotinuric Acid (NUA)
    Time Frame
    Predose on Day 1 up to 48 hours postdose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Post-pubescent adolescent age 10 to 16 with heterozygous familial hypercholesterolemia Agree to use (and/or have their partner use) acceptable methods of birth control beginning at the prestudy visit until at least 2 weeks after dosing of study drug Height and weight fall between the 10th and 95th percentile for age with a minimum body weight of 23 kg Receiving appropriate medical care for hypercholesterolemia, such as a statin or other lipid-modifying therapy. Exclusion Criteria: History of psychiatric or personality disorders that may affect the patient's ability to participate History of stroke, chronic seizures, or major neurological disorder History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases (excluding lipid abnormalities) Poorly controlled or recently diagnosed Type 1 or Type 2 diabetes mellitus History of neoplastic disease within previous 5 years Consumes alcohol or excessive amounts of products that contain caffeine (e.g. cola) Has had major surgery, donated and/or received blood within previous 8 weeks Participated in another investigational study within previous 4 weeks History of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food Positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV) Cannot swallow large tablets Pregnant or breastfeeding

    12. IPD Sharing Statement

    Learn more about this trial

    A Study of Extended-release (ER) Niacin/Laropiprant in Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0524A-158)

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