Chronic pain Signs and Symptoms
Conditions
Interventions
Each participant will receive a single buccal dose of Empli-03 Buccal Tablet, 0.8 mg on one occasion after receiving two 50 mg oral doses of naltrexone hydrochloride, and before a third 50 mg oral dos
Sponsors
Emplicure AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Must provide written informed consent 2. Must be willing and able to communicate and participate in the whole study 3. Must understand and agree to keep the IMP in place for the full 6 h of dosing 4. Aged 18 to 55 years inclusive at the time of signing informed consent 5. Must agree to adhere to the contraception requirements defined in the clinical protocol 6. Healthy males or non-pregnant, non-lactating healthy females 7. Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, as measured at screening 8. Weight =50 kg at screening
Exclusion criteria
Exclusion criteria: 1. Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients. 2. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active. 3. History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease (cholecystectomy is allowed), neurological or psychiatric disorder, as judged by the investigator. 4. Subject has a medical condition that may adversely affect taste or smell activity. 5. Subject has a medical condition that causes chronic pain or requires regular pain management with medication. 6. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening. 7. Evidence of poor dental status, e.g. (but not limited to) poor oral hygiene, local irritation or ulcers at site of administration, or long-term dry mouth, as confirmed by an oral examination at screening and admission. 8. Evidence of current SARS-CoV-2 infection within 28 days of IMP administration. 9. Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator. Subjects with Gilbert’s Syndrome are allowed. 10. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results. 11. Females who are pregnant or lactating. 12. Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1, or less than 5 elimination half-lives prior to Day 1, whichever is longer. 13. Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood. 14. Subjects who report to have received buprenorphine within the past 30 days, at the discretion of the Investigator. 15. Subjects who are taking, or have taken, any prescribed or over-the-counter drug or vitamin/herbal remedies (other than up to 4 g of paracetamol per day only on occasion with a maximum of 2-3 days use in a row, HRT and contraceptive pill/hormonal contraception) in the 14 days before IMP administration. COVID-19 vaccines are accepted concomitant medications. 16. History of any drug or alcohol abuse. 17. Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type). 18. A confirmed positive alcohol breath test at screening or admission. 19. Current smokers and those who have smoked within the last 12 months. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission. 20. Current users of e-cigarettes, nicotine replacement products and nicotine containing products and those who have used these products within the last 12 months. 21. Confirmed positive drugs of abuse test result. 22. Opioid usage during the last year, or long-term usage (>4 weeks), at the discretion of the Investigator. 23. Subjects who are, or are immediate family members of, a study site or sponsor employee. 24. Failure to satisfy the investigator of fitness to participate for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters including, but not limited to Cmax, AUC(0-last), and AUC(0-inf) for buprenorphine and norbuprenorphine measured using blood samples taken at multiple timepoints up to 72 h post dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional safety and tolerability information for the test product: adverse events (AEs), vital signs, ECGs, physical examinations, local tolerance, and safety laboratory tests from the time of signing the informed consent form up until discharge from the study | — |
Countries
England, United Kingdom
Contacts
Public ContactAnna Franzén
Outcome results
None listed