Study of Nasal Formulations in Healthy Volunteers (QSC203197)
Research type
Research Study
Full title
A Randomised Sequence, Open-Label, Cross-Over Study to Evaluate the Bioavailability of Investigational Nasal Nalmefene Formulations in Healthy Subjects
IRAS ID
277131
Contact name
Martin Jönsson
Contact email
Sponsor organisation
Orexo AB
Eudract number
2019-004864-23
Duration of Study in the UK
0 years, 1 months, 21 days
Research summary
The Sponsor, Orexo AB, are developing new formulations (recipes) of the test medicine, nalmefene, to reverse the effects of opioid overdose. Opioids are a class of pain relief drugs including the illegal drug heroin and the legal drugs codeine and morphine and their misuse can lead to overdosing. The test medicine is already available in the EU and Australia in a tablet form (SELINCRO®) for the treatment of alcohol dependence. \n\nThis study will investigate how nalmefene is absorbed by the body from the nasal test formulations compared to a reference test medicine injection formulation. This study will also look at the safety and tolerability of the test medicine. \n\nThe study involves one study visit, consisting of 4 treatment periods, including up to 20 healthy male and non-pregnant/lactating female volunteers. The estimated time from screening until the follow-up phone call is up to approximately 7 weeks. Volunteers will be admitted to the clinic in the evening of Day -1. Volunteers will receive 4 single doses of the test medicine in the fasted state, each on a separate dosing occasion (Day 1, 4, 7 and 10), three in the form of a nasal powder spray and one in the form of a buttock injection. Between each dosing occasion there will be a minimum washout period of 72 hours. The order volunteers will receive each test medicine formulation will be randomised. \n\nDischarge procedures will be performed 36 hours after the volunteers have received their final dose of the test medicine and will be discharged on Day 11, however volunteers will have the option to remain resident to the morning of Day 12 if they prefer. Volunteers will have a follow-up call 3 to 5 days after their last dose to check on their continued wellbeing.
REC name
Wales REC 2
REC reference
20/WA/0032
Date of REC Opinion
21 Feb 2020
REC opinion
Further Information Favourable Opinion