RB-EU-14-0001 - Phase 1 Study in Healthy Volunteers
Research type
Research Study
Full title
A Single-Centre, Open-Label, Bioavailability Study Comparing Abuse-Deterrent Oral Capsules Containing Buprenorphine Hemiadipate Hydrochloride, in the Presence and Absence of Food, with SUBUTEX® Sublingual Tablets in Healthy Volunteers under Naltrexone Block
IRAS ID
184784
Contact name
Ronnie Beboso
Contact email
Sponsor organisation
Indivior Inc., a subsidiary of Indivior PLC
Eudract number
2015-002278-19
Duration of Study in the UK
0 years, 3 months, 23 days
Research summary
This is a phase 1, 2-part, open-label study performed by Indivior Inc., a subsidiary of Indivior PLC. The purpose is to investigate how the body handles RBP-6300 ADF and its breakdown products in healthy adult volunteers.
This trial will be conducted in two parts. In Part A RBP-6300 ADF will be compared to SUBUTEX, a drug which is already marketed. It will also be compared in a fed (a high fat breakfast) and non-fasted state.
In Part B, two further concentrations of RBP-6300 ADF will be investigated.
RBP-6300 ADF is a drug that may be useful in the treatment of addiction.
The trial will be carried out in Quintiles, Drug Research Unit, London. The total duration of the trial will be approximately 77 days in Part A and approximately 35 days in Part B.
REC name
HSC REC A
REC reference
15/NI/0133
Date of REC Opinion
4 Aug 2015
REC opinion
Favourable Opinion