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

Merck Sharp & Dohme (MSD)

Status and phase

Terminated

Phase 1

Conditions

Hypercholesterolemia, Familial

Heterozygous Familial Hypercholesterolemia

Treatments

Drug: MK-0524A

Study type

Interventional

Funder types

Industry

Identifiers

NCT01583647

0524A-158

2012-001443-49 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

10 to 16 years old

Volunteers

No Healthy Volunteers

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