Stiripentol Bioavailability Study in Healthy Participants
Research type
Research Study
Full title
Comparative, Randomized, Single-Dose, 2-Way Crossover Bioavailability Study of TUR-004 and The Reference Formulation in Healthy Adult Subjects Under Fasted Conditions.
IRAS ID
191859
Contact name
Brendan Colgan
Contact email
Sponsor organisation
Turing Pharmaceuticals LLC
Eudract number
2015-004361-91
Duration of Study in the UK
0 years, 0 months, 14 days
Research summary
Stiripentol is an antiepileptic drug, first identified in 1978, with early development starting in the 1980s, intended for the treatment of patients with Dravet Syndrome (DS), a rare and serious form of epilepsy which affects very young children primarily. Stiripentol was conditionally approved in Europe in 2007 as Diacomit®.\n\nTuring is developing TUR 004, a stiripentol formulation for the treatment of patients with DS, the objective is to design a suitable formulation with comparable pharmacokinetic performances and safety profile to the marketed reference treatment,Diacomit®. \n\nThis is an open label, randomized, 2 period, 2 way crossover, 2 sequence study under fasted conditions. in which twenty-eight (28), healthy adult male and female subjects will be enrolled..\n
REC name
HSC REC A
REC reference
15/NI/0214
Date of REC Opinion
24 Nov 2015
REC opinion
Further Information Favourable Opinion