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Nasal Human Abuse Potential of PTI-821

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03475862
Recruitment Status : Completed
First Posted : March 23, 2018
Last Update Posted : March 23, 2018
PRA Health Sciences
Information provided by (Responsible Party):
PainT ( Pain Therapeutics )

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.

Condition or disease Intervention/treatment Phase
Opioid Abuse Nondependent Drug: PTI-821 capsule Manipulated Drug: PTI-821 Non-manipulated Drug: OxyContin Other: Placebo Drug: Oxycodone Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 4-way single-dose crossover with an exploratory 5th treatment arm
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind, double-dummy
Primary Purpose: Other
Official Title: 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)
Actual Study Start Date : May 15, 2017
Actual Primary Completion Date : July 31, 2017
Actual Study Completion Date : December 15, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: PTI-821 Manipulated
oxycodone 40 mg capsule
Drug: PTI-821 capsule Manipulated
PTI-821 (oxycodone) 40 mg extended release capsule

Active Comparator: Oxycodone
Oxycodone 40 mg IR tablet crushed
Drug: Oxycodone
Crushed oxycodone 40 mg immediate release tablet

Active Comparator: OxyContin
Oxycodone ER 40 mg tablet crushed
Drug: OxyContin
Crushed OxyContin (oxycodone) extended-release 40 mg tablet

Placebo Comparator: Placebo
Matching placebos for experimental and active comparator arms
Other: Placebo
Matching placebos for PTI-821 and oxycodone IR

Experimental: PTI-821 Non-manipulated
Oxycodone 40 mg non-manipulated
Drug: PTI-821 Non-manipulated
PTI-821 (oxycodone) 40 mg capsule extended release capsule

Primary Outcome Measures :
  1. Drug Liking Emax [ Time Frame: Intervals from 0.5 hours to 12 hours post dose ]
    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.

Secondary Outcome Measures :
  1. Take Drug Again [ Time Frame: 12 and 25 hours ]
    Desire to take drug again if offered based on bipolar visual analog scale from 0-100 where o is most negative response, 50 is neutral, and 100 is the most positive response.

  2. Drug effects questionnaire [ Time Frame: Intervals from 0.5 hours to 12 hours post dose ]
    Assesses various drug effects such as good drug effects, bad drug effects, high and nausea/dizziness

  3. Peak Plasma Concentration (Cmax) [ Time Frame: Intervals from 15 minutes to 24 hours post-dose ]
    Maximum plasma concentration

  4. Area under the plasma concentration versus time curve [ Time Frame: Intervals from 15 minutes to 24 hours post-dose ]
    Amount of drug absorbed at various timepoints

  5. Time to maximum plasma concentration (Tmax) [ Time Frame: Intervals from 15 minutes to 24 hours post-dose ]
    The time intervals from the first dose to the peak plasma concentration

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria::

  • 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).

Exclusion Criteria:

  • 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.
  • Pregnant females; breastfeeding females; males and females of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for 28 days after the last dose of study medication. Urine pregnancy tests must be collected and confirmed negative prior to dosing upon admission.
  • Is currently taking a drug for a medical condition or a nutraceutical that poses a safety risk when administered with an opioid, cannot be safely withdrawn at Screening for the duration of the study, and/or will adversely affect the PD and safety assessments required by the study. Examples include antihypertensive agents, drugs for seizures, and diabetes medications. Hormonal contraceptives (oral, injected, intrauterine, transdermal or implanted) are allowed in this study provided the subject remains on the same treatment throughout the entire study and has been using that hormonal contraceptive for an adequate period of time to ensure effectiveness. Limited use of non-prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the investigator. As an exception, acetaminophen may be used at doses of 1 g/day.
  • Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 30 days prior to dosing.
  • Unwilling or unable to comply with the procedures described in this protocol.
  • Unwilling to be searched (including personal effects) for illicit substances before admission to the study center.
  • Subject is a heavy smoker (> 20 cigarettes per day on average in the past 30 days prior to Screening), chews tobacco, uses nicotine-containing products (including nicotine transdermal patches), and/or is unable to abstain from smoking for at least 10 hours during any day.
  • Current pending legal charges or currently on probation.
  • Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are PTI employees directly involved in the conduct of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03475862

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United States, Utah
Salt Lake City, Utah, United States, 84106
Sponsors and Collaborators
Pain Therapeutics
PRA Health Sciences
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Principal Investigator: Lynn Webster, MD PRA Health Sciences

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Responsible Party: Pain Therapeutics Identifier: NCT03475862     History of Changes
Other Study ID Numbers: PTI-821-C08
First Posted: March 23, 2018    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents