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Single Ascending Dose Study of ALA-1000

2019-10-16 10:39:25 | BioPortfolio

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.

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

Conditions

Opioid-use Disorder

Intervention

ALA-1000, buprenorphine sublingual film

Location

Innovative Clinical Research
Miami
Florida
United States
33016

Status

Recruiting

Source

Alar Pharmaceuticals Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-16T10:39:25-0400

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Medical and Biotech [MESH] Definitions

A derivative of the opioid alkaloid THEBAINE that is a more potent and longer lasting analgesic than MORPHINE. It appears to act as a partial agonist at mu and kappa opioid receptors and as an antagonist at delta receptors. The lack of delta-agonist activity has been suggested to account for the observation that buprenorphine tolerance may not develop with chronic use.

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