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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypercholesterolemia, Familial; Heterozygous Familial Hypercholesterolemia

Intervention: MK-0524A (Drug); MK-0524A (Drug)

Phase: Phase 1

Status: Terminated

Sponsored by: Merck Sharp & Dohme Corp.


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

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)


Minimum age: 10 Years. Maximum age: 16 Years. Gender(s): Both.


Inclusion Criteria:

- Post-pubescent adolescent age 10 to 16 with heterozygous familial


- 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

Locations and Contacts

Additional Information

Starting date: June 2012
Last updated: April 27, 2015

Page last updated: August 23, 2015

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