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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Hypercholesterolemia, Familial; Heterozygous Familial Hypercholesterolemia	Drug: MK-0524A	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	10 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ER Niacin/Laropiprant in Adolescents With Heterozygous Familial Hypercholesterolemia
Study Start Date :	June 2012
Actual Primary Completion Date :	December 2012
Actual Study Completion Date :	December 2012

Arms and Interventions

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Arm	Intervention/treatment
Experimental: MK-0524A 1 g/20 mg (Panel A); Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg	Drug: MK-0524A; 1 tablet of MK-0524A (1g ER niacin/20mg laropripant) orally; Other Name: Extended-release (ER) Niacin/Laropiprant
Experimental: MK-0524A 2 g/40 mg (Panel B); Single oral dose of 2 tablets of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg	Drug: MK-0524A; 2 tablets of MK-0524A (1g ER niacin/20mg laropripant) orally; Other Name: Extended-release (ER) Niacin/Laropiprant

Outcome Measures

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Primary Outcome Measures :

1. Plasma Area Under the Concentration Curve From 0 to Infinity (AUC0-∞) of Laropiprant [ Time Frame: Predose Day 1 up to 24 hours postdose ]
2. Plasma Maximum Concentration (Cmax) of Laropiprant [ Time Frame: Predose on Day 1 up to 48 hours postdose ]
3. Total Urinary Excretion of Niacin and Niacin Metabolites [ Time Frame: Predose on Day 1 up to 72 hours postdose ]
4. Plasma Cmax of Nicotinuric Acid (NUA) [ Time Frame: Predose on Day 1 up to 48 hours postdose ]

Eligibility Criteria

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Ages Eligible for Study:	10 Years to 16 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT01583647 History of Changes
Other Study ID Numbers:	0524A-158; 2012-001443-49 ( EudraCT Number )
First Posted:	April 24, 2012
Results First Posted:	December 4, 2013
Last Update Posted:	November 3, 2015
Last Verified:	November 2015

Additional relevant MeSH terms:

Hypercholesterolemia; Hyperlipoproteinemia Type II; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Hyperlipoproteinemias; Niacin; Niacinamide	Nicotinic Acids; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Vasodilator Agents; Vitamin B Complex; Vitamins; Micronutrients; Growth Substances; Physiological Effects of Drugs