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

NCT03002961 Phase 1 COMPLETED

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.

Details

Lead sponsor	Indivior Inc.
Phase	Phase 1
Status	COMPLETED
Enrolment	48
Start date	2012-07
Completion	2013-10

Conditions

• Opioid Use Disorder

Interventions

• RBP-6000
• Suboxone

Primary outcomes

• Safety will be assessed by the frequency of adverse events (AEs), serious AEs, and discontinuations due to AEs (safety and tolerability) in subjects receiving a single dose of RBP-6000. — Baseline (defined as last non-missing value prior to dosing) to end of study/day 150 or early termination
  Safety will be assessed by AEs, ECGs, laboratory measurements, local injection site tolerability and vital signs
• Individual, mean and median PK concentrations over time profiles will be plotted for subjects receiving a single dose of RBP-6000 with an adequate number of PK samples collected to derive PK parameters. — PK prior to injection through Day 150/End of Study or Early Termination
  Individual plasma concentrations will be collected to compute PK parameters. The individual concentrations will be summarized using descriptive statistics.
• The safety of RBP-6000 when administered as a single SC injection after daily dosing of SL Suboxone will be assessed as a measure of the occurrence of AEs, serious AEs and discontinuations due to AEs — Day -7 through Day 150/End of Study or Early Termination
  Safety to be assessed by AEs, ECGs, laboratory measurements, local injection site tolerability and vital signs

Countries

United States