3-Period Study to Investigate Prototype Formulations of Diazepam
Research type
Research Study
Full title
An Open-label, Single-dose, Non-Randomised 3-Period Study to Investigate Prototype Formulations of Diazepam
IRAS ID
232042
Contact name
Dominic Capone
Contact email
Sponsor organisation
Antares Pharma
Eudract number
2017-003052-23
Duration of Study in the UK
0 years, 1 months, 22 days
Research summary
The Sponsor is developing concentrated formulations of the study drug, intramuscular diazepam, for the potential out-of-hospital treatment of epileptic seizures. \n\nThe purpose of this study is to determine the pharmacokinetics (how well the study drug is taken up by the body) and relative bioavailability (the amount of the study drug that reaches the blood stream) of 2 new concentrated formulations of intramuscular diazepam in comparison to a currently marketed formulation.\n\nThe study will consist of 3 periods involving up to 20 healthy volunteers. The subjects will receive single doses of each investigational medicinal product (IMP) across 3 treatment periods. In Period 1, the subjects will receive a dose of the currently marketed formulation, 10 mg Diazepam solution. In Period 2, the subjects will receive a dose of 10 mg Diazepam prototype formulation 1. In Period 3, the subjects will receive a dose of 10 mg Diazepam prototype formulation 2. The subjects will receive the doses in a fixed sequence with at least 14 days between doses. Each dose will be given as an intramuscular (IM) injection to the deltoid (rounded outer edge of the shoulder) muscle. \n\nBlood samples will be taken before each dose is given and at selected time points up to 14 days post-dose. These blood samples will be used to test the amounts of diazepam and des-methyl diazepam (a breakdown product of diazepam) in the plasma at different time points after the dose. \n
REC name
HSC REC B
REC reference
17/NI/0165
Date of REC Opinion
29 Sep 2017
REC opinion
Further Information Favourable Opinion