Single Ascending Dose Study of ALA-1000

Status Completed

Clinical Trial Summary

An open-label study designed to evaluate the safety, tolerability, and pharmacokinetics of ALA-1000 in opioid-dependent subjects. To characterize the PK profile of ALA-1000 in 5 single ascending dose cohorts and a sixth cohort of single ALA-1000 after receiving buprenorphine sublingual films for 7 days.

Clinical Trial Description

The study will include opioid-dependent subjects who have been receiving stable, orally administered buprenorphine for at least 2 weeks or buprenorphine naïve subjects who will be stabilized on orally administered buprenorphine for 3 days prior to ALA-1000 administration. All subjects will be washed off of oral buprenorphine for 7 days prior to ALA-1000 administration except Cohort 6 which will receive ALA-1000 administration after 7 days of buprenorphine sublingual film dosing. The subsequent cohorts will be initiated after safety and PK information from the preceding cohorts is available. The expected maximum duration of participation for each subject is 192 days approximately, consisting of up to a 7-day screening period, up to a 31-day residential phase, and up to a 154-day nonresidential period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04122755
Study type	Interventional
Source	Alar Pharmaceuticals Inc.
Contact
Status	Completed
Phase	Phase 1
Start date	September 16, 2019
Completion date	May 3, 2021

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