None listed
Conditions
Brief summary
The sponsor has developed a wafer formulation of buprenorphine to be administered under the tongue. The buprenorphine wafer will be compared to intravenous buprenorphine (marketed in Australia as Temgesic). Healthy volunteers may participate in the study. Participants will complete two inpatient sessions, with admission the afternoon before dosing, followed by 48 hours of observation after dosing. Participants will receive a single dose of intravenous buprenorphine 300mcg during one inpatient session and a single dose of sublingual (under-the-tongue) buprenoprhine wafer 800 mcg during another session. Naltrexone is given to block opioid effects. The two inpatient sessions will be separated by a minimum of 7 days. No food will be allowed for 10 hours prior to and four hours following dosing.
Interventions
Participants will complete two inpatient sessions, with admission the afternoon before dosing, followed by 48 hours of observation after dosing. Study staff will administer to participants a single dose of intravenous buprenorphine 300mcg during one inpatient session and a single dose of sublingual (under-the-tongue) buprenoprhine wafer 800 mcg during another session. Study staff will observe the oral cavity to ensure sublingual buprenorphine wafer is dissolved. To block the opioid effects of bu
Participants will complete two inpatient sessions, with admission the afternoon before dosing, followed by 48 hours of observation after dosing. Study staff will administer to participants a single dose of intravenous buprenorphine 300mcg during one inpatient session and a single dose of sublingual (under-the-tongue) buprenoprhine wafer 800 mcg during another session. Study staff will observe the oral cavity to ensure sublingual buprenorphine wafer is dissolved. To block the opioid effects of buprenorphine, 50 mg oral naltrexone will be administered 12 hours and 1 hour pre-dose and 12 hours post-dose. The two inpatient sessions will be separated by a minimum of 7 days. No food will be allowed for 10 hours prior to and four hours following dosing.
Sponsors
iX Biopharma Pty Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Good general health without clinically significant renal, hepatic, cardiac or respiratory disease, as determined by the Principal Investigator. 2. Have suitable venous access for blood sampling. 3. Female participants must not be pregnant or lactating and must be using a reliable form of birth control. 4. BMI within the range of 19-30 kg/m2 (inclusive). 5. Deemed able to read and understand English in order to communicate with research staff and complete protocol required questionnaires and forms.
Exclusion criteria
1. Has a laboratory value at the Screening Visit that is outside the normal range (including positive serology for Hepatitis B, C or HIV). 2. Any gastrointestinal condition which could affect drug absorption. 3. History (within the last six months) of or current clinically significant psychiatric disorder including anxiety, psychosis or depression. 4. Current inflammatory or ulcerative disease of the oral cavity that could impair the absorption of sublingual medication. 5. History of severe allergic or anaphylactic drug-related reactions. 6. History of hypersensitivity to buprenorphine or naltrexone or any of the excipients of the sublingual wafer. 7. Intake of any prescribed or Over-The-Counter (OTC)/non-prescribed drugs, vitamins/supplements, or herbal medicines, within 2 weeks of administration of investigational product/reference listed product (or longer if the medication has a half-life long enough to potentially expose the healthy participant to any significant systemic exposure). 8. Use of drugs with enzyme-inducing properties (such as rifampicin and St John’s Wort) within 3 weeks or 5 half-lives, whichever is greater, prior to treatment period 1 and throughout the study, or any drug known to be a strong inhibitor of CYP3A4 within 5 half-lives of treatment period 1 and throughout the study. 9. Participation in another clinical trial of an investigational agent within 30 days of study entry. 10. Clinically significant, as determined by the Investigator, abnormal ECG (12-lead) or vital signs at the screening visit or pre-dose (Day 1). 11. Known or suspected drug (including analgesic drugs or tranquilizers) or alcohol abuse or dependence. 12. Positive results on the urine drug screen or breath alcohol test at screening and/or pre-dose. 13. Any alcohol use within 24 hours prior to Day -1 in each of the inpatient treatment periods.
Outcome results
None listed