A Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ER Niacin/Laropiprant in Adolescents With Heterozygous Familial Hypercholesterolemia
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 10
- Primary Endpoint
- Plasma Area Under the Concentration Curve From 0 to Infinity (AUC0-∞) of Laropiprant
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 10 Years to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: MK-0524A (Drug)
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
Intervention: MK-0524A (Drug)
Outcomes
Primary Outcomes
Plasma Area Under the Concentration Curve From 0 to Infinity (AUC0-∞) of Laropiprant
Time Frame: Predose Day 1 up to 24 hours postdose
Plasma Maximum Concentration (Cmax) of Laropiprant
Time Frame: Predose on Day 1 up to 48 hours postdose
Total Urinary Excretion of Niacin and Niacin Metabolites
Time Frame: Predose on Day 1 up to 72 hours postdose
Plasma Cmax of Nicotinuric Acid (NUA)
Time Frame: Predose on Day 1 up to 48 hours postdose
Secondary Outcomes
No secondary outcomes reported