A Study of Extended-release (ER) Niacin/Laropiprant in Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0524A-158)
This study has been terminated.
(In HPS2-THRIVE, MK-0524A did not meet the primary efficacy objective and there was a significant increase in incidence of some types of non-fatal SAEs.)
Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01583647
First received: April 20, 2012
Last updated: December 1, 2014
Last verified: December 2014
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypercholesterolemia, Familial Heterozygous Familial Hypercholesterolemia |
Drug: MK-0524A |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ER Niacin/Laropiprant in Adolescents With Heterozygous Familial Hypercholesterolemia |
Resource links provided by NLM:
Genetics Home Reference related topics:
Chanarin-Dorfman syndrome
cholesteryl ester storage disease
hypercholesterolemia
MedlinePlus related topics:
Cholesterol
Genetic and Rare Diseases Information Center resources:
Hyperlipoproteinemia Type 2
Sphingolipidosis
U.S. FDA Resources
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- Plasma Area Under the Concentration Curve From 0 to Infinity (AUC0-∞) of Laropiprant [ Time Frame: Predose Day 1 up to 24 hours postdose ] [ Designated as safety issue: No ]
- Plasma Maximum Concentration (Cmax) of Laropiprant [ Time Frame: Predose on Day 1 up to 48 hours postdose ] [ Designated as safety issue: No ]
- Total Urinary Excretion of Niacin and Niacin Metabolites [ Time Frame: Predose on Day 1 up to 72 hours postdose ] [ Designated as safety issue: No ]
- Plasma Cmax of Nicotinuric Acid (NUA) [ Time Frame: Predose on Day 1 up to 48 hours postdose ] [ Designated as safety issue: No ]
| Enrollment: | 10 |
| Study Start Date: | June 2012 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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
|
Drug: MK-0524A
1 tablet of MK-0524A (1g ER niacin/20mg laropripant) orally
Other Name: Extended-release (ER) Niacin/Laropiprant
|
|
Experimental: 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
|
Drug: MK-0524A
2 tablets of MK-0524A (1g ER niacin/20mg laropripant) orally
Other Name: Extended-release (ER) Niacin/Laropiprant
|
Eligibility| Ages Eligible for Study: | 10 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
No Contacts or Locations Provided
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT01583647 History of Changes |
| Other Study ID Numbers: | 0524A-158, 2012-001443-49 |
| Study First Received: | April 20, 2012 |
| Results First Received: | October 7, 2013 |
| Last Updated: | December 1, 2014 |
| Health Authority: | Norway: Norwegian Medicines Agency United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hypercholesterolemia Hyperlipoproteinemia Type II Dyslipidemias Genetic Diseases, Inborn Hyperlipidemias Hyperlipoproteinemias Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Niacin Niacinamide Nicotinic Acids |
Antimetabolites Cardiovascular Agents Growth Substances Hypolipidemic Agents Lipid Regulating Agents Micronutrients Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses Vasodilator Agents Vitamin B Complex Vitamins |
ClinicalTrials.gov processed this record on March 03, 2015