Safety, tolerability and PK of subcutaneous Buprenorphine (QCL117942)
Research type
Research Study
Full title
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a Novel Subcutaneous Depot Formulation of Buprenorphine (INDV-6200) in Healthy Volunteers
IRAS ID
229861
Contact name
Frank Gray
Contact email
Sponsor organisation
Indivior UK Ltd.
Eudract number
2017-001133-11
Duration of Study in the UK
0 years, 4 months, 17 days
Research summary
Buprenorphine is a medicine used for the treatment of opioid addiction with a well established efficacy and safety profile. Opioids are drugs that act on the nervous system to relieve pain.
The Sponsor is developing a new long-acting formulation of buprenorphine for subcutaneous (under the skin) injection, for the treatment of opioid addiction. The injection is designed to allow slow steady release of buprenorphine over time. The injection deposits buprenorphine in a contained mass under the skin, called a depot, from which buprenorphine is gradually absorbed by surrounding tissue. This is therefore more convenient to the user as fewer clinical visits are required, and can therefore improve compliance in taking the medicine.
The study will consist of 2 periods. Fifteen healthy volunteers will participate in Period 1 which will assess tolerability of oral buprenorphine (SUBUTEX) and oral naltrexone, a medicine which will be used to reduce the potential side effects of buprenorphine.
Twelve of these volunteers, who have shown tolerability to oral buprenorphine and naltrexone, will then participate in Period 2 where they will receive 20 mg buprenorphine or placebo as a subcutaneous injection. In period 2 volunteers will also receive oral naltrexone.
There is also an option to dose another group of volunteers, as above, but with an alternative dose of the buprenorphine subcutaneous injection which will be dependent on the results of Period 1.
REC name
HSC REC A
REC reference
17/NI/0150
Date of REC Opinion
25 Aug 2017
REC opinion
Favourable Opinion