Opioid Use Disorder Clinical Trial
Official title:
A Single-Dose, Open-Label Study of Depot Buprenorphine (RBP-6000) in Opioid-Dependent Individuals
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.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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