Clinical trial NCT01583647: A Study of Extended-release (ER) Niacin/Laropiprant in Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0524A-158)
Official title: A Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ER Niacin/Laropiprant in Adolescents With Heterozygous Familial Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Hypercholesterolemia, Familial
Heterozygous Familial Hypercholesterolemia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2012-04-24
Enrollment: 10
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Plasma Area Under the Concentration Curve From 0 to Infinity (AUC0-∞) of Laropiprant
timeFrame: Predose Day 1 up to 24 hours postdose
measure: Plasma Maximum Concentration (Cmax) of Laropiprant
timeFrame: Predose on Day 1 up to 48 hours postdose
measure: Total Urinary Excretion of Niacin and Niacin Metabolites
timeFrame: Predose on Day 1 up to 72 hours postdose
measure: Plasma Cmax of Nicotinuric Acid (NUA)
timeFrame: Predose on Day 1 up to 48 hours postdose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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