Up to 6-Period Study in Prototype Formulations of Diazepam (QSC201145)
Research type
Research Study
Full title
An Open-Label, Single-Dose, Non-Randomised, up to 6-Period Study to Investigate Prototype Formulations of Diazepam
IRAS ID
249563
Contact name
Dominic Capone
Contact email
Eudract number
2018-002428-17
Duration of Study in the UK
0 years, 6 months, 27 days
Research summary
The Sponsor is developing concentrated formulations of the study drug (diazepam), for the potential out of-hospital treatment of epileptic seizures (fits). The diazepam is delivered via an injection into the muscle (intramuscular).\n\nThe purpose of this study is to determine the pharmacokinetics (how well diazepam is taken up by the body), the relative bioavailability (the amount of diazepam that reaches the blood stream) and bioequivalence (does the amount of diazepam that reaches the blood stream match that of the marketed product) of 2 new concentrated formulations of intramuscular diazepam in comparison to a currently marketed formulation. The site of injection is also to be investigated. \n\nThe study will consist of up to 6 periods involving up to 20 healthy male and female volunteers who are not able to have children. Each subject will receive up to 6 single doses of intramuscular diazepam. In Period 1, subjects will receive a dose of the currently marketed formulation, 10 mg Diazepam solution, to the deltoid muscle, a muscle located on the uppermost part of the arm and the top of the shoulder. \n\nIn the following periods, subjects will receive a single dose of 10 mg diazepam in either the prototype formulations or the marketed formulation. The intramuscular injections will be delivered to either the deltoid muscle or the thigh muscle. The decision on which formulation and injection site will be determined following review of the study data from the previous period. \n\nBlood samples will be taken before each dose is given and at selected time points up to 14 days after dosing. 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. Saftey assessment will also be performed thorough each Period.\n
REC name
London - Surrey Borders Research Ethics Committee
REC reference
18/LO/1315
Date of REC Opinion
24 Jul 2018
REC opinion
Favourable Opinion