Study of Empli-03 Buccal Tablet Formulation in Naltrexone Blocked Healthy Subjects (QSC206680)
Research type
Research Study
Full title
A Single Period Open-Label Study Designed to Evaluate the Pharmacokinetics of Empli-03 Buccal Tablet Formulation in Naltrexone-Blocked Healthy Subjects
IRAS ID
1005812
Contact name
Anna Franzén
Contact email
Sponsor organisation
Emplicure AB
ISRCTN Number
ISRCTN12656966
Research summary
The Sponsor is developing a new recipe, Empli-03, of an already approved active ingredient, buprenorphine, for the potential treatment of chronic pain. Empli-03 is a buccal tablet, which means it is administered orally by placing it between the gum and the upper lip. \nThis single period, healthy volunteer study will try to identify how the test medicine is taken up, broken down and removed by the body. The safety and tolerability of the test medicine will also be investigated.\nThis study will take place at one non-NHS site, enrolling up to 12 male/female volunteers aged 18 – 55 years (inclusive).\nVolunteers will receive a single dose of the test medicine on the morning of Day 1 and will be required to hold the tablet under the upper lip for approximately 6 hours. Within 10 mins of the tablet being removed, volunteers will be asked to complete a questionnaire about how it tasted and how comfortable the tablet was. \nA mouth check will be required by the study doctor during screening, pre-dose and post-dose to check on volunteer wellbeing and for any reactions to the mouth following dosing. Photos of the mouth will also be taken as part of this check.\nNaltrexone Hydrochloride will be given in this study to help minimise any side effects from buprenorphine (the active ingredient in the test medicine). Volunteers will receive single doses of Naltrexone Hydrochloride on at least 3 occasions. These doses will be given on Day -1, on Day 1 approximately 1 hour pre-dose of the test medicine and on Day 1 approximately 12 hours post-dose of the test medicine. \nAfter dosing, volunteers will be required to remain at the clinical unit and will be discharged on Day 4. Volunteers will receive a follow up phone call, between Day 8 and 10.\nVolunteer’s blood and urine will be taken throughout the study for analysis of the test medicine and for their safety. \nVolunteers are expected to be involved in this study for approximately 6 weeks from screening to the follow up call.
REC name
London - Harrow Research Ethics Committee
REC reference
22/FT/0105
Date of REC Opinion
1 Sep 2022
REC opinion
Further Information Favourable Opinion