The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic profile of an injection of RBP-6000.
This is an open-label, single-center, first-in-human study, designed to evaluate the safety, tolerability and pharmacokinetic (PK) profile of a single subcutaneous (SC) injection of RBP-6000 in opioid dependent subjects. Enrollment will begin with 6 subjects, and additional subjects will not be enrolled until safety through Day 4 has been reviewed and analyzed. Subjects will remain in a residential unit through Day 30 post-injection and will continue with visits to the clinical unit until Day 85 or plasma buprenorphine levels are below 100 pg/mL, whichever comes later. The expected maximum duration of participation for each subject (including screening) is 120 days. Safety will be assessed by adverse events, electrocardiograms, clinical laboratory assessments, local injection site tolerability and vital signs. PK will be assessed by measuring concentrations of buprenorphine and norbuprenorphine in plasma. The need for rescue medication will be assessed using clinical judgment along with information provided by the COWS scores.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
A single injection of RBP-6000 containing a low dose of buprenorphine in the Atrigel delivery system
Scientific Clinical Research
Fort Lauderdale, Florida, United States
To assess the incidence of treatment emergent adverse events (safety and tolerability) of a single SC injection of RBP-6000 in subjects with opioid dependence.
The frequency of all adverse events (AE) and serious adverse events (SAE) deemed to be related to treatment.
Time frame: Day 1 to Day 85
Maximum plasma concentration (Cmax) for buprenorphine and norbuprenorphine
PK samples to be collected to determine Cmax over the post-injection period
Time frame: Day 1 through Day 85
Time to occurrence of Cmax (Tmax) for buprenorphine and norbuprenorphine
PK samples to be collected to determine Tmax over the post-injection period
Time frame: Day 1 through Day 85
Area under the plasma concentration versus time curve (AUC) for buprenorphine and norbuprenorphine
AUC to be measured from time 0 to the last sampling time post-injection at which concentrations were at or above the limit of quantitation
Time frame: Day 1 through Day 85
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