Relative bioavailability of OX382 capsules (QCL118142)
Research type
Research Study
Full title
A fasting, open-label, 3-treatment, 3-period, randomized sequence, cross-over study to evaluate the relative bioavailability of two buprenorphine capsule formulations in comparison to a tablet formulation administered orally in healthy volunteers under naltrexone block
IRAS ID
235392
Contact name
Martin Jönsson
Contact email
Sponsor organisation
Orexo AB
Eudract number
2016-004762-25
Duration of Study in the UK
0 years, 1 months, 24 days
Research summary
The sponsor is developing two capsule formulations (recipes) of OX382, OX382-A and OX382-B, to be taken by mouth. The Sponsor is developing new formulations of OX382 for the potential treatment of opioid dependence (addiction). \n\nTreatment for opioid dependence is currently available as sublingual tablets. These are tablets which are placed under the tongue and kept there until they are fully dissolved, which usually occurs within 5 to 10 minutes. This can be uncomfortable for some patients which means sometimes the tablets are swallowed which leads to poor absorption by the body. \n\nThis study will try to identify if OX382-A and OX382-B allow for better rates of absorption by the body when compared to the reference product, the sublingual tablet (SUBUTEX), after all formulations are swallowed. The study will also compare the 2 new formulations, and assess their safety and tolerability. \n\nThe study will consist of 3 periods involving up to 12 healthy male and female (non-pregnant and non-lactating) volunteers. Volunteers will swallow each of the formulations (OX382-A, OX382-B and SUBUTEX) in turn, one each period in a randomised order. Volunteers will be pre-treated with naltrexone before taking each formulation and will take naltrexone up to 24 hours after doing (4 doses in total, each period). Naltrexone is a medicine which will be used to reduce the potential side effects of each formulation. Up to 16 volunteers will receive naltrexone prior to dosing in the first study period in order to ensure dosing of 12 volunteers.\n\nAfter each administration volunteers will remain in the clinical for 72 hours (3 days) for blood samples and safety assessments to be performed. \n
REC name
Wales REC 2
REC reference
17/WA/0355
Date of REC Opinion
22 Nov 2017
REC opinion
Favourable Opinion