drugset / Trial / NCT03002961

Single Ascending Dose Study of RBP-6000

NCT03002961

Phase 1 Completed 48 enrolled Indivior Inc.
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2012-07
Primary completion
2013-02
Completion
2013-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Buprenorphine Other / unclassified 12 mg Other
Subject RBP-6000 Unknown Subcutaneous

Indications