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drugset / Trial / NCT01738503

Multiple Dose Pharmacokinetics Depot Buprenorphine in Opioid-Dependent Subjects

NCT01738503 ↗

Phase 2 Completed 124 enrolled Indivior Inc.
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is an open-label study in treatment seeking opioid-dependent subjects for safety, tolerability, pharmacokinetics (PK), efficacy markers, and opioid receptor availability of subcutaneous injections of depot buprenorphine after induction and stabilization of treatment seeking subjects onto Subutex. Subjects were planned to receive 4 subcutaneous (SC) injections of RBP-6000 separated by 28 days (Cohorts 1-5) or 6 SC injections of RBP-6000 separated by 28 days (Cohort 6) after a 13-day induction and dose stabilisation period on SUBUTEX Sublingual (SL) tablet at dose levels of 8-24 mg.

Timeline

Start
2012-10
Primary completion
2014-05
Completion
2014-05

Drugs

EvaluationDrugModalityDoseRoute
Subject RBP-6000 Unknown 50 mg Subcutaneous
Subject RBP-6000 Unknown 100 mg Subcutaneous
Subject RBP-6000 Unknown 200 mg Subcutaneous
Subject RBP-6000 Unknown 300 mg Subcutaneous
Background Buprenorphine Other / unclassified 8 mg Other
Background Buprenorphine Other / unclassified 12 mg Other
Background Buprenorphine Other / unclassified 14 mg Other
Background Buprenorphine Other / unclassified 24 mg Other

Indications

opiate dependence