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

Study Overview
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Brief Summary
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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.

Official Title
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A Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ER Niacin/Laropiprant in Adolescents With Heterozygous Familial Hypercholesterolemia

Conditions
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Hypercholesterolemia, Familial, Heterozygous Familial Hypercholesterolemia

Intervention / Treatment
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* Drug: MK-0524A
* Drug: MK-0524A


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MK-0524A 1 g/20 mg (Panel A)<br>Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg | Drug: MK-0524A<br>* 1 tablet of MK-0524A (1g ER niacin/20mg laropripant) orally<br>* Other names: Extended-release (ER) Niacin/Laropiprant;|
| Experimental: MK-0524A 2 g/40 mg (Panel B)<br>Single oral dose of 2 tablets of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg | Drug: MK-0524A<br>* 2 tablets of MK-0524A (1g ER niacin/20mg laropripant) orally<br>* Other names: Extended-release (ER) Niacin/Laropiprant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Area Under the Concentration Curve From 0 to Infinity (AUC0-∞) of Laropiprant |  | Predose Day 1 up to 24 hours postdose | 
| Plasma Maximum Concentration (Cmax) of Laropiprant |  | Predose on Day 1 up to 48 hours postdose | 
| Total Urinary Excretion of Niacin and Niacin Metabolites |  | Predose on Day 1 up to 72 hours postdose | 
| Plasma Cmax of Nicotinuric Acid (NUA) |  | Predose on Day 1 up to 48 hours postdose |