drugset / Trial / NCT03715634

Study of a Novel Subcutaneous Depot Formulation of Buprenorphine

NCT03715634

Phase 1 Completed 12 enrolled Indivior Inc.
RandomizedSequentialSingle-blindTreatment

Summary

INDV-6200 is being developed for the treatment of opioid dependency and is expected to provide sustained buprenorphine plasma concentrations. The study will be done in healthy volunteers and will administer a non-therapeutic dose of INDV-6200. Study Period 1 will evaluate the oral tolerability of sublingual (SL) buprenorphine dosed over 3 days. Period 2 will administer the investigational medicinal product (IMP) or volume matched placebo.

Timeline

Start
2017-09-20
Primary completion
2018-06-07
Completion
2018-06-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Buprenorphine Other / unclassified Subcutaneous
Background Nalorex Unknown

Indications