Nasal Human Abuse Potential of PTI-821

NCT03475862 | Completed Phase 1 FDA Drug

• 1 other identifier: PTI-821-C08
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Drug Liking Emax

  Peak effect for drug liking based on bipolar visual analog scale from 0-100 where 0 is most negative response, 50 is neutral, and 100 is most positive response.

  Intervals from 0.5 hours to 12 hours post dose

Secondary Outcomes (5)

• Take Drug Again

  12 and 25 hours

• Drug effects questionnaire

  Intervals from 0.5 hours to 12 hours post dose

• Peak Plasma Concentration (Cmax)

  Intervals from 15 minutes to 24 hours post-dose

• Area under the plasma concentration versus time curve

  Intervals from 15 minutes to 24 hours post-dose

• Time to maximum plasma concentration (Tmax)

  Intervals from 15 minutes to 24 hours post-dose

Study Arms (5)

PTI-821 Manipulated

EXPERIMENTAL

oxycodone 40 mg capsule

Drug: PTI-821 capsule Manipulated

Oxycodone

ACTIVE COMPARATOR

Oxycodone 40 mg IR tablet crushed

Drug: Oxycodone

OxyContin

ACTIVE COMPARATOR

Oxycodone ER 40 mg tablet crushed

Drug: OxyContin

Placebo

PLACEBO COMPARATOR

Matching placebos for experimental and active comparator arms

Other: Placebo

PTI-821 Non-manipulated

EXPERIMENTAL

Oxycodone 40 mg non-manipulated

Drug: PTI-821 Non-manipulated

Interventions

PTI-821 capsule Manipulated DRUG

PTI-821 (oxycodone) 40 mg extended release capsule

PTI-821 Manipulated

PTI-821 Non-manipulated DRUG

PTI-821 (oxycodone) 40 mg capsule extended release capsule

PTI-821 Non-manipulated

OxyContin DRUG

Crushed OxyContin (oxycodone) extended-release 40 mg tablet

OxyContin

Placebo OTHER

Matching placebos for PTI-821 and oxycodone IR

Placebo

Oxycodone DRUG

Crushed oxycodone 40 mg immediate release tablet

Oxycodone

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and/or female subjects between the ages of 18 and 55 years,
• Subject is a recreational opioid user who is NOT dependent on opioids
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and body weight \> 50 kg (110lbs).
• Evidence of a personally signed and dated informed consent document
• Subjects must be willing and able to comply with study procedures.
• Females who are physically incapable of childbearing, or practicing an acceptable method of birth control. Acceptable methods of birth control include surgical sterilization, hormonal contraceptives, or double-barrier methods (condom or diaphragm with a spermicidal agent or intrauterine device).

You may not qualify if:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
• Diagnosis of substance and/or alcohol dependence (excluding caffeine and nicotine).
• Has participated in, is currently participating in, or is seeking treatment for substance- and/or alcohol-related disorders (excluding nicotine and caffeine).
• Has a positive urine drug screen (UDS) excluding tetrahydrocannabinol (THC) at Screening and the admission for Qualification Phase.
• Has a positive alcohol breath test at Screening or upon admission to the study center for the Qualification Phase.
• Has any history of a condition in which an opioid is contraindicated
• History of sleep apnea in the past 5 years that has not been resolved.
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject unsuitable for entry into this study.
• Positive test for Hepatitis B, Hepatitis C, or HIV at Screening.
• Allergy or history of hypersensitivity to naloxone hydrochloride (HCl), oxycodone HCl, other opioids, and/or lactose.
• Any condition possibly affecting drug absorption.
• Physical (eg, constricted or collapsed veins) or mental obstruction (ie, phobia) that would prevent serial blood sample collection.
• Clinically significant illness in the judgment of the investigator within 30 days before Screening.
• Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first treatment during the Qualification Period (Visit 2), if longer than 30 days.
• Screening BP \> 140 mm Hg (systolic) or \> 90 mm Hg (diastolic) following at least 5 minutes of rest. If BP is \> 140 mm Hg (systolic) or \> 90 mm Hg (diastolic), the BP should be repeated two more times and the average of the three BP values should be used to determine the subject's eligibility.

Sponsors & Collaborators

• Pain Therapeutics: lead
• PRA Health Sciences: collaborator

Study Sites (1)

PRA-EDS

Salt Lake City, Utah, 84106, United States

Location

MeSH Terms

Interventions

Oxycodone

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Lynn Webster, MD

  PRA Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind, double-dummy
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 4-way single-dose crossover with an exploratory 5th treatment arm

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: March 23, 2018
• Study Start: May 15, 2017
• Primary Completion: July 31, 2017
• Study Completion: December 15, 2017
• Last Updated: March 23, 2018

Record last verified: 2018-03

Locations

US (1)