Crossover, bioequivalence study of idalopirdine in healthy subjects
Research type
Research Study
Full title
Interventional, randomised, open-label, two-way crossover, single-dose bioequivalence study of idalopirdine in healthy subjects comparing the 60 mg commercial tablet (test) to the 60 mg clinical tablet (reference)
IRAS ID
171197
Contact name
Sunu Valasseri
Contact email
Sponsor organisation
H. Lundbeck A/S
Eudract number
2014-001799-69
Duration of Study in the UK
0 years, 1 months, 24 days
Research summary
Lu AE58054 (idalopirdine) is a selective 5-HT6 receptor (a chemical receptor molecule in the brain) blocker, which is being developed for the symptomatic treatment of mild to moderate Alzheimer’s Disease (AD). And is anticipated to provide additional clinical efficacy when administered along with other medications like donepezil. Idalopirdine is currently being tested in a global phase III development programme in doses of 10, 30 and 60 mg/day.
An immediate release tablet formulation was developed mainly for clinical studies, however, the formulation used in clinical trials required modification for commercialization. The modifications include, change in polymorphic form to the most thermodynamically stable (stable under different environmental conditions) form, addition of colour to the coating and an increase of the amount of coating.
This study aims to establish that the two pharmaceutical formulations (i.e.: clinical tablet and commercial tablet) are similar in terms of drug absorption, blood concentrations, and elimination (bioequivalence) when administered with a same dose, and therefore the commercial tablet formulation can be marketed based on clinical data generated in the pivotal studies.
This study is an interventional, randomised, open-label, two-way cross-over (receiving one tablet form in each period), single-dose study. Each subject will attend two treatment periods, on each of these visits the volunteers will receive a single dose of one of the tablets and will be discharged from the unit on day 4. The dosing in the next period will be at least 7 days after the first dose. The subjects will receive each tablet form only once. The subjects will be randomised such that an equal number of subjects will be assigned to the treatments in each of the two sequences.
In the clinical pharmacology studies, idalopirdine was well tolerated in single doses up to 360 mg and multiple doses up to 300 mg/day and no subjects withdrew due to adverse events.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
15/SC/0016
Date of REC Opinion
18 Feb 2015
REC opinion
Further Information Favourable Opinion