DDI evaluation of ZX008 and Probe Drugs in HV (117731)
Research type
Research Study
Full title
A Randomized, Open-label, Single-dose, 3-way Crossover Study to Evaluate the Drug-drug Interaction Between ZX008 (Fenfluramine Hydrochloride) Oral Solution and Stiripentol Regimen (Stiripentol/Clobazam/Valproate) in Healthy Volunteers
IRAS ID
198176
Contact name
Stuart Mair
Contact email
Sponsor organisation
Zogenix International Limited, A subsidiary of Zogenix, Inc.
Eudract number
2015-005791-24
Duration of Study in the UK
0 years, 2 months, 2 days
Research summary
The Sponsor is developing the study drug, ZX008, for the potential treatment of Dravet Syndrome (DS). \n\nCurrently DS is treated with a combination of medication (stiripentol, clobazam and valproate) known as Stiripentol regimen. The study will consist of 3 regimens designed to evaluate the drug-drug interaction of the study drug and the stiripentol regimen. Subjects will randomly be allocated to receive each of the following treatments over the 3 study regimens:\n•\tRegimen A: A single dose of ZX008 0.8 mg/kg\n•\tRegimen B: Stiripentol 3500 mg/CLOB 20 mg/VPA 25 mg/kg (maximum 1500 mg)\n•\tRegimen C: ZX008 0.8 mg/kg mg plus stiripentol 3500 mg/CLOB 20 mg/VPA 25 mg/kg (maximum 1500 mg)\n\n24 healthy male and female subjects will be enrolled to achieve a minimum of 16 evaluable subjects that will have received the 3 study regimens.\n
REC name
Wales REC 1
REC reference
16/WA/0010
Date of REC Opinion
4 Feb 2016
REC opinion
Favourable Opinion