Intra-subject Variability and Pharmacokinetics of Lomitapide
Research type
Research Study
Full title
A Phase 1, Open-label, Crossover Study to Determine the intra-subject variability of the Pharmacokinetics of Single Oral Capsule Dose of 20 mg Lomitapide in Healthy Subjects
IRAS ID
135789
Contact name
Ulrike Lorch
Contact email
Sponsor organisation
Aegerion Pharmaceuticals, SAS.
Eudract number
2013-002692-17
ISRCTN Number
n/a
Research summary
We are conducting a clinical study at Richmond Pharmacology Ltd (RPL) clinical research unit with a new medicine known as lomitapide. Lomitapide is being developed by Aegerion Pharmaceuticals, Inc (the sponsor company) to treat Homozygous Familial Hypercholesterolemia. HoFH is a rare inherited disease in which patients have very high cholesterol levels of LDL (“bad“) cholesterol and that is inherited from both parents. Lomitapide has previously been tested in several clinical trials and found to be safe and tolerable and is able to reduce LDL levels. Since HoFH may be passed genetically from parents to their children; the sponsor company plans to conduct a clinical trial in children with the lomitapide sprinkled onto sweet foods or drinks as children cannot swallow the capsule. Prior to doing so, it is important to establish the variability of uptake of lomitapide when taken as an intact capsule which can be compared to the uptake in sprinkled foods in subsequent studies. The aim of this study is to determine the variation of uptake of lomitapide within each person when they take lomitapide on 2 separate occasions. The results from this study will help us design clinical trials of lomitapide in children. Standard safety assessments will include laboratory tests (haematology, biochemistry and urinalysis), vital signs, physical examinations, ECG and PK. Volunteers will have to follow a low-fat diet (<20% of energy from fat) for 4 days of the study.
Volunteers will be required to attend a screening visit within 28 days before the start of the study. The study will take approximately 55 days to complete including 2 residential periods (stays in our unit) of 9 days and 8 nights during each period; during which time they will receive a single dose of lomitapide on Day 1.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
13/SC/0342
Date of REC Opinion
26 Jul 2013
REC opinion
Further Information Favourable Opinion