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Nasal Human Abuse Potential of PTI-821

NCT03475862 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2018-03-23

No results posted yet for this study

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.

Conditions

  • Opioid Abuse Nondependent

Interventions

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

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • Pain Therapeutics

    lead INDUSTRY

Principal Investigators

  • Lynn Webster, MD · PRA Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-15
Primary Completion
2017-07-31
Completion
2017-12-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03475862 on ClinicalTrials.gov