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

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

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.

Study Overview

• Status: Terminated
• Conditions: Hypercholesterolemia, Familial; Heterozygous Familial Hypercholesterolemia
• Intervention / Treatment: Drug: MK-0524A; Drug: MK-0524A

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Extended-release (ER) Niacin/Laropiprant; Drug: MK-0524A; 2 tablets of MK-0524A (1g ER niacin/20mg laropripant) orally; Other Names: 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; 1 tablet of MK-0524A (1g ER niacin/20mg laropripant) orally; Other Names: Extended-release (ER) Niacin/Laropiprant; Drug: MK-0524A; 2 tablets of MK-0524A (1g ER niacin/20mg laropripant) orally; Other Names: Extended-release (ER) Niacin/Laropiprant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: April 20, 2012
• First Submitted That Met QC Criteria: April 23, 2012
• First Posted (Estimate): April 24, 2012

Study Record Updates

• Last Update Posted (Estimate): November 3, 2015
• Last Update Submitted That Met QC Criteria: November 2, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Metabolism, Inborn Errors; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Lipid Metabolism, Inborn Errors; Hyperlipoproteinemias; Hypercholesterolemia; Hyperlipoproteinemia Type II; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Antimetabolites; Micronutrients; Hypolipidemic Agents; Lipid Regulating Agents; Vitamins; Vitamin B Complex; Nicotinic Acids; Niacinamide; Niacin
• Other Study ID Numbers: 0524A-158; 2012-001443-49 (EudraCT Number)