NCT03475862

Nasal Human Abuse Potential of PTI-821

A Randomized, Double-Blind, Placebo-Controlled, Double-Dummy, Single-Dose,4-Way Crossover Study With Exploratory Fifth Treatment to Determine the Relative Nasal Abuse Potential of PTI-821 (Oxycodone Extended-Release Capsules)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Pain Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The study will evaluate the human abuse liability of PTI-821 (oxycodone extended-release capsules) when administered nasally compared to crushed oxycodone IR tablets and crushed OxyContin tablets, also administered nasally.

Detailed description

The nasal human abuse liability of PTI-821 will be compared to oxycodone IR using pharmacokinetic and pharmacodynamic assessments. A comparison to OxyContin will be dose using pharmacokinetic assessments.

Conditions

• Opioid Abuse Nondependent

Interventions

Type	Name	Description
DRUG	PTI-821 capsule Manipulated	PTI-821 (oxycodone) 40 mg extended release capsule
DRUG	PTI-821 Non-manipulated	PTI-821 (oxycodone) 40 mg capsule extended release capsule
DRUG	OxyContin	Crushed OxyContin (oxycodone) extended-release 40 mg tablet
OTHER	Placebo	Matching placebos for PTI-821 and oxycodone IR
DRUG	Oxycodone	Crushed oxycodone 40 mg immediate release tablet

Timeline

• Start date: 2017-05-15
• Primary completion: 2017-07-31
• Completion: 2017-12-15
• First posted: 2018-03-23
• Last updated: 2018-03-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study