Study of IV NPJ5008 and DANTRIUM IV® in Healthy Volunteers(QSC204721)
Research type
Research Study
Full title
A Single Centre, 2-part, Part-Randomised, Open-Label, Intravenous, Single Dose Study Designed to Compare the Relative Bioavailability of Novel Intravenous NPJ5008 with DANTRIUM IV® in Healthy Volunteers
IRAS ID
292173
Contact name
Steve Hayes
Contact email
Sponsor organisation
Norgine, Ltd.
Eudract number
2020-005719-35
Duration of Study in the UK
0 years, 1 months, 26 days
Research summary
Research Summary\nThe Sponsor is developing the test medicine NPJ5008 to treat a rare and life-threatening condition called fulminant hypermetabolic crisis (FHC) triggered by anaesthetic gases, antipsychotic medications or extreme exertion/exercise. Symptoms include muscle rigidity and increasing body temperature. There are currently no medicines marketed specifically to treat FHC.\n\nThe test medicine (NPJ5008) is given directly into the veins and contains the active ingredient dantrolene. Dantrolene is currently marketed in the EU as DANTRIUM IV®. This study will compare the new medicine to DANTRIUM IV® the reference medicine used to treat malignant hyperthermia (FHC caused by exposure to anaesthetic gases).\n\nThis is the first time the test medicine has been given to people. This study consists of two parts. Part 1 will compare the amount of dantrolene in the blood when NPJ5008 and DANTRIUM IV® are given to see if they are similar and see how safe and well tolerated the test medicine is when given at a low dose. Part 2 will look at the safety and tolerability of higher doses of the test medicine, similar to the doses that would be given to patients.\n\nPart 1 will include up to 16 healthy volunteers attending 2 visits (screening, study period of 9 overnight stays). Each volunteer will receive a single 60 mg dose of the test medicine and a single 60 mg dose of DANTRIUM IV® in turn, with at least 5 days in between. \n\nPart 2 will include up to 10 healthy volunteers attending 2 visits (screening, study period of 4 overnight stays). Each volunteer will receive a single dose of either 120 mg or 240 mg of test medicine.\n\nSentinel dosing will be used in both parts.\n\nA follow up phone call will take place 5 to 7 days after the final-dose to ensure the ongoing wellbeing of volunteers.\n\nSummary of Results\nGiven that this is a phase 1 trial, no lay summary of results has been provided for reasons of commercial confidentiality.
REC name
HSC REC A
REC reference
21/NI/0013
Date of REC Opinion
2 Feb 2021
REC opinion
Favourable Opinion