NCT03002961

Single Ascending Dose Study of RBP-6000

A Multicenter, Open-Label, Single Ascending-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Depot Buprenorphine (RBP-6000) in Opioid-Dependent Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Indivior Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A multi-center, open-label, single ascending dose study to enroll opioid dependent treatment-seeking subjects. Subjects to be enrolled into 3 cohorts receiving low, medium and high doses of depot buprenorphine. A fourth cohort will be enrolled to evaluate the PK of RBP-6000 after receiving suboxone tablets for 7 days.

Detailed description

All subjects will undergo screening period of up to 7 days. Eligible subjects in Cohorts 1-3 will receive RBP-6000 doses on at the conclusion of screening. Subjects in Cohort 4 will receive sublingual (SL) Suboxone for 7 days prior to receiving an injection of RBP-6000. For all cohorts, subjects will be admitted to the clinic 2 days prior to beginning any dosing, and will remain in the clinic through Day 21. Blood collection for hematology, chemistry and serology analysis will be drawn at screening, and intermittently for safety assessments during the study period. Subjects in Cohorts 1-3 will have a PK sample collected pre-dose and serial PK collection post-dosing. Subjects in Cohort 4 will have daily PK collections while admitted during Suboxone dosing and serially after RBP-6000 administration. Subjects will return to the clinic for PK sample collection through Day 140 or until buprenorphine concentrations fall below 100 pg/mL. Subjects will return to the clinic for safety assessments through Day 150. Subjects experiencing signs and symptoms of withdrawal prior to RBP-6000 during the residential phase may receive non-opioid rescue medications. Subjects who experience signs and symptoms of withdrawal may receive hydromorphone beginning on Day 11 if necessary. Methadone dosing can begin, if clinically indicated, on Day 16 only for subjects who have not been administered hydromorphone. Subjects will not be allowed to use buprenorphine at any time during the study. Subjects will also receive psychosocial and behavioral counseling as specified by the PI. The End of Study visit will occur 1 week after Day 84 or 1 week after the monthly follow-up visits after Day 84, given a subject's buprenorphine plasma concentration has fallen below 100 pg/mL. For subjects with plasma concentrations of buprenorphine above 100 pg/mL at Day 140, Day 150 will be the End of Study visit. Subjects will not be enrolled into the next cohort until safety data for at least the first 6 subjects has been reviewed.

Conditions

• Opioid Use Disorder

Interventions

Type	Name	Description
DRUG	RBP-6000	single dose of RBP-6000, preceded by a pharmacokinetic (PK) sample followed by serial PK samples post-dose. Additionally subjects to remain in the clinic through Day 21 for safety assessments
DRUG	Suboxone	RBP-6000 injection after 7 days of SL Suboxone administration. Interventions as above with additional daily PK collections during Suboxone treatment prior to RBP-6000 administration

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-02-01
• Completion: 2013-10-01
• First posted: 2016-12-26
• Last updated: 2016-12-26

Locations

1 site across 1 country: United States