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

Phase 1

Terminated

• Conditions: Heterozygous Familial Hypercholesterolemia; Hypercholesterolemia, Familial
• Interventions: Drug: MK-0524A

• Registration Number: NCT01583647
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-20
• Study First Submitted QC: 2012-04-23
• Study First Posted: 2012-04-24
• Study Start: 2012-06
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Results First Submitted: 2013-10-07
• Results First Submitted QC: 2013-10-07
• Results First Posted: 2013-12-04
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-02
• Last Update Posted: 2015-11-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MK-0524A 1 g/20 mg (Panel A)	MK-0524A	Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
MK-0524A 2 g/40 mg (Panel B)	MK-0524A	Single oral dose of 2 tablets of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg

Primary Outcome Measures

Name	Time	Method
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