Study to Evaluate the Safety and PK of ER Niacin/Laropiprant
Research type
Research Study
Full title
A Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ER Niacin/Laropiprant in Adolescents with Heterozygous Familial Hypercholesterolemia
IRAS ID
117706
Contact name
Saikat Santra
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2012-001443-49
Clinicaltrials.gov Identifier
Research summary
This is an open label, multicenter, single dose study in pediatric patients with heterozygous familial hypercholesterolemia to evaluate the pharmacokinetics and tolerability of MK-0524A when administered to pediatric patients. In children with familial hypercholesterolemia, dietary and statin therapies are the mainstays of treatment to reduce the risk of coronary artery disease. Supplemental treatment with niacin may help to reduce the risk of cardiovascular disease by raising HDL-C (good cholesterol) and lowering triglycerides. Niacin therapy is associated with an unacceptably high incidence ofluhing-related intolerability in children, which limits its use. Laropiprant is being developed in combination with extended release niacin in children to reduce these side-effects. This study is intended to provide an initial assessment of safety and tolerability, to characterize the pharmacokinetics of niacin and laropiprant in post pubertal adolescents and to compare these results in adults. Up to 2 panels of 12 patients each will receive single oral doses of MK-0524A. Patients in Panel A will receive a single dose of MK-0524A 1g/20mg (1 tablet of Niacin/laropiprant 1g/20mg) with 200ml water following a low fat breakfast. Patients in Panel B will receive a single dose of MK-0524A 2g/40mg (2 tablets of ER Niacin/Laropiprant 1g/20mg) with 200ml water following a low-fat breakfast. Water will be restricted 1 hour prior to and after study drug administration. Patients are required to fast for at least 8 hours. Blood samples will be collected predose and at specified time points post dose up to 48 hours for laropiprant, 24 hours for nicotinic acid/nicotinuric plasma concentrations. Urine will be collected predose and up to 72 hours post dose for evaluation of niacin and metabolites. The study duration is 9 months and for each study patient approximately 4 weeks. Merck Sharp and Dohme Corp is the sponsor and patients will be recruited at 3 Children's Hospitals.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
12/WM/0371
Date of REC Opinion
20 Nov 2012
REC opinion
Favourable Opinion