A study in healthy volunteers to investigate how the test medicine Empli-03 buccal tablet is taken up, broken down and removed by the body
| ISRCTN | ISRCTN12656966 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12656966 |
| IRAS number | 1005812 |
| Secondary identifying numbers | Sponsor code: Empli-03 |
- Submission date
- 15/08/2022
- Registration date
- 15/08/2022
- Last edited
- 11/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
Background and study aims
The Sponsor is developing a new formulation, 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.
This 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.
Who can participate?
Healthy males or non-pregnant, non-lactating healthy females aged 18 to 55 years.
What does the study involve?
The study consists of one part, involving a single cohort of 12 volunteers. Volunteers 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. Naltrexone hydrochloride is given in this study to help minimise any side effects from buprenorphine (the active ingredient in the test medicine), on Day -1, and on Day 1, approximately 1 hour before and approximately 12 hours after the dose of the test medicine. Volunteers enter the unit on Day -1 and are discharged on Day 4. Volunteers will receive a follow-up phone call, between Day 8 and 10. Volunteers’ blood and urine will be taken throughout the study for analysis of the test medicine and for their safety. Volunteers are expected to be involved in this study for approximately 6 weeks from screening to the follow-up call.
What are the possible risks and benefits of participating?
Participants get no medical benefit from taking part in the study. However, the development of a treatment for chronic pain may benefit the population as a whole. It is considered that the risk /benefit evaluation in this study supports the use of healthy volunteers. Full information on possible side effects is provided to volunteers in the Participant Information Sheet and Informed Consent Form. Volunteers are closely monitored during the study and safety assessments are performed regularly.
Where is the study run from?
Emplicure AB (Sweden)
When is the study starting and how long is it expected to run for?
October 2022 to November 2022
Who is funding the study?
Emplicure AB
Who is the main contact?
Anna Franzén, anna.franzen@emplicure.com
Contact information
Principal Investigator
Mere Way
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
United Kingdom
| Phone | +44 (0)330 303 1000 |
|---|---|
| recruitment@weneedyou.co.uk |
Public, Scientific
Emplicure AB
Virdings Alle 32b
Uppsala
754 50
Sweden
| Phone | +46 (0)708 59 35 |
|---|---|
| anna.franzen@emplicure.com |
Study information
| Study design | Pharmacokinetic trial in healthy volunteers |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Pharmaceutical testing facility |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | A single-period open-label study designed to evaluate the pharmacokinetics of Empli-03 buccal tablet formulation in naltrexone-blocked healthy subjects |
| Study objectives | The trial will meet the following primary and secondary objectives: Primary Objective: To determine the PK of buprenorphine and norbuprenorphine following administration of an Empli-03 buccal tablet formulation in naltrexone-blocked healthy volunteers. Secondary Objective: To provide additional safety and tolerability information for an Empli-03 buccal tablet formulation in naltrexone-blocked healthy volunteers. |
| Ethics approval(s) | Approved 01/09/2022, London Harrow REC (Bristol HRA Centre, Temple Quay House, 2 The Square, Temple Quay, Bristol, BS1 6PN, United Kingdom; harrow.rec@hra.nhs.uk), ref: 22/FT/105 |
| Health condition(s) or problem(s) studied | Chronic pain |
| Intervention | 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 dose of naltrexone hydrochloride. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Pharmacokinetic |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | Empli-03 (INN: buprenorphine hydrochloride) |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 28/07/2022 |
| Completion date | 02/11/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 55 Years |
| Sex | Both |
| Target number of participants | 12 |
| Total final enrolment | 12 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 03/10/2022 |
| Date of final enrolment | 02/11/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
United Kingdom
Sponsor information
Industry
Virdings Alle 32b
Uppsala
754 50
Sweden
| Phone | +46 (0)708 59 35 |
|---|---|
| anna.franzen@emplicure.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | In accordance with the approved HRA deferral, full trial details have now been published in the registry. |
| IPD sharing plan | The datasets generated and/or analysed during the current study are not expected to be made available because of their high commercial sensitivity and the negligible benefit to the public of publication of results of nontherapeutic clinical trials. |
Editorial Notes
11/04/2025: The information for which publication was previously deferred has been added to the following fields:
1. The public title
2. The scientific title
3. Study hypothesis
4. Condition
5. Interventions
6. Drug/device/biological/vaccine name(s)
7. Pharmaceutical study type(s)
8. Study setting(s)
9. Study type(s)
10. Primary outcome measure
11. Secondary outcome measures
12. Participant inclusion criteria
13. Participant exclusion criteria
14. Lower and upper age limits and units
15. Plain English summary
16. Publication and dissemination plan
17. The recruitment start date was changed from 19/09/2022 to 03/10/2022.
18. The recruitment end date was changed from 03/10/2022 to 02/11/2022.
19. Contact and sponsor details updated.
09/09/2022: The HRA has confirmed that it has approved deferral.
15/08/2022: Trial's existence confirmed by the MHRA.
