Opioid Abuse NondependentPhase 1NCT03475862
Nasal Human Abuse Potential of PTI-821
A Phase 1 study testing PTI-821 capsule Manipulated, PTI-821 Non-manipulated and OxyContin in people with Opioid Abuse Nondependent, run by Pain Therapeutics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Abuse Nondependent
- What is being tested?
- PTI-821 capsule Manipulated, PTI-821 Non-manipulated and OxyContin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2017to 15 Dec 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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
- Being tested
- PTI-821 capsule Manipulated, PTI-821 Non-manipulated, OxyContin, Placebo, Oxycodone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTI-821 capsule ManipulatedDrug
PTI-821 (oxycodone) 40 mg extended release capsule
PTI-821 Non-manipulatedDrug
PTI-821 (oxycodone) 40 mg capsule extended release capsule
OxyContinDrug
Crushed OxyContin (oxycodone) extended-release 40 mg tablet
PlaceboOther
Matching placebos for PTI-821 and oxycodone IR
OxycodoneDrug
Crushed oxycodone 40 mg immediate release tablet
| Study group | Role | What they receive |
|---|---|---|
| PTI-821 Manipulated | Experimental | oxycodone 40 mg capsule Receives: Drug: PTI-821 capsule Manipulated |
| Oxycodone | Active comparator | Oxycodone 40 mg IR tablet crushed Receives: Drug: Oxycodone |
| OxyContin | Active comparator | Oxycodone ER 40 mg tablet crushed Receives: Drug: OxyContin |
| Placebo | Placebo comparator | Matching placebos for experimental and active comparator arms Receives: Other: Placebo |
| PTI-821 Non-manipulated | Experimental | Oxycodone 40 mg non-manipulated Receives: Drug: PTI-821 Non-manipulated |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intervals from 0.5 hours to 12 hours post dose
Secondary outcomes (5)
Take Drug Again
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.
Measured: 12 and 25 hours
Drug effects questionnaire
Assesses various drug effects such as good drug effects, bad drug effects, high and nausea/dizziness
Measured: Intervals from 0.5 hours to 12 hours post dose
Peak Plasma Concentration (Cmax)
Maximum plasma concentration
Measured: Intervals from 15 minutes to 24 hours post-dose
Area under the plasma concentration versus time curve
Amount of drug absorbed at various timepoints
Measured: Intervals from 15 minutes to 24 hours post-dose
Time to maximum plasma concentration (Tmax)
The time intervals from the first dose to the peak plasma concentration
Measured: Intervals from 15 minutes to 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start15 May 2017
- Primary completion31 Jul 2017
- Study completion15 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Abuse NondependentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 4-way single-dose crossover with an exploratory 5th treatment arm
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pain Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Responsible party
- Sponsor
- Investigators
- Lynn Webster, MD, Principal investigator, PRA Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475862
- Sponsor's protocol ID
- PTI-821-C08
- Status last verified
- Mar 2018
- First submitted
- 7 Mar 2018
- Last updated
- 23 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03475862
- Acronym / sponsor ID
- PTI-821-C08
- Conditions
- Opioid Abuse Nondependent
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Pain TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Study start
- 15 May 2017 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 23 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- 4-way single-dose crossover with an exploratory 5th treatment arm
| Arm | Type | Receives |
|---|---|---|
| PTI-821 Manipulated | Experimental | Drug: PTI-821 capsule Manipulatedoxycodone 40 mg capsule |
| Oxycodone | Active comparator | Drug: OxycodoneOxycodone 40 mg IR tablet crushed |
| OxyContin | Active comparator | Drug: OxyContinOxycodone ER 40 mg tablet crushed |
| Placebo | Placebo comparator | Other: PlaceboMatching placebos for experimental and active comparator arms |
| PTI-821 Non-manipulated | Experimental | Drug: PTI-821 Non-manipulatedOxycodone 40 mg non-manipulated |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PTI-821 capsule ManipulatedPTI-821 (oxycodone) 40 mg extended release capsule | Drug | PTI-821 Manipulated |
| PTI-821 Non-manipulatedPTI-821 (oxycodone) 40 mg capsule extended release capsule | Drug | PTI-821 Non-manipulated |
| OxyContinCrushed OxyContin (oxycodone) extended-release 40 mg tablet | Drug | OxyContin |
| PlaceboMatching placebos for PTI-821 and oxycodone IR | Other | Placebo |
| OxycodoneCrushed oxycodone 40 mg immediate release tablet | Drug | Oxycodone |
Primary outcome
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.
5 secondary outcomes
Take Drug Again
Time frame: 12 and 25 hours
Drug effects questionnaire
Time frame: Intervals from 0.5 hours to 12 hours post dose
Peak Plasma Concentration (Cmax)
Time frame: Intervals from 15 minutes to 24 hours post-dose
Area under the plasma concentration versus time curve
Time frame: Intervals from 15 minutes to 24 hours post-dose
Time to maximum plasma concentration (Tmax)
Time frame: Intervals from 15 minutes to 24 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynn Webster, MD principal investigator
PRA Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PTI-821 capsule Manipulated, PTI-821 Non-manipulated and OxyContin in people with Opioid Abuse Nondependent, run by Pain Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug Liking Emax (time frame: Intervals from 0.5 hours to 12 hours post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2018.