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

NCT ID: NCT01583647

Last Updated: 2015-11-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2012-12-31

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.

Conditions

Hypercholesterolemia, Familial; Heterozygous Familial Hypercholesterolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

MK-0524A

Intervention Type: DRUG

1 tablet of MK-0524A (1g ER niacin/20mg laropripant) orally

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

Group Type: EXPERIMENTAL

MK-0524A

Intervention Type: DRUG

2 tablets of MK-0524A (1g ER niacin/20mg laropripant) orally

Interventions

MK-0524A

1 tablet of MK-0524A (1g ER niacin/20mg laropripant) orally

Intervention Type: DRUG

MK-0524A

2 tablets of MK-0524A (1g ER niacin/20mg laropripant) orally

Intervention Type: DRUG

Other Intervention Names

Extended-release (ER) Niacin/Laropiprant; Extended-release (ER) Niacin/Laropiprant

Eligibility 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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2012-001443-49

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

0524A-158

Identifier Type: -

Identifier Source: org_study_id