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

• Status: Terminated
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Niacin; Niacinamide; Nicotinic Acids

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