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

Heterozygous Familial Hypercholesterolemia Clinical Trial

Official title:

A Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ER Niacin/Laropiprant in Adolescents With Heterozygous Familial Hypercholesterolemia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01583647
• Other study ID #: 0524A-158
• Secondary ID: 2012-001443-49
• Status: Terminated
• Phase: Phase 1
• First received: April 20, 2012
• Last updated: November 2, 2015
• Start date: June 2012
• Est. completion date: December 2012

Study information

• Verified date: November 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 16 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heterozygous Familial Hypercholesterolemia
• Hypercholesterolemia
• Hypercholesterolemia, Familial
• Hyperlipoproteinemia Type II

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Area Under the Concentration Curve From 0 to Infinity (AUC0-8) of Laropiprant		Predose Day 1 up to 24 hours postdose	No
Primary	Plasma Maximum Concentration (Cmax) of Laropiprant		Predose on Day 1 up to 48 hours postdose	No
Primary	Total Urinary Excretion of Niacin and Niacin Metabolites		Predose on Day 1 up to 72 hours postdose	No
Primary	Plasma Cmax of Nicotinuric Acid (NUA)		Predose on Day 1 up to 48 hours postdose	No