Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03475862 | Nasal Human Abuse Potential of PTI-821 | PHASE1 | COMPLETED | 38 | — | — | May 15, 2017 | Dec 15, 2017 | Mar 23, 2018 | 1 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| PTI-821 Manipulated | EXPERIMENTAL | oxycodone 40 mg capsule |
| Oxycodone | ACTIVE_COMPARATOR | Oxycodone 40 mg IR tablet crushed |
| OxyContin | ACTIVE_COMPARATOR | Oxycodone ER 40 mg tablet crushed |
| Placebo | PLACEBO_COMPARATOR | Matching placebos for experimental and active comparator arms |
| PTI-821 Non-manipulated | EXPERIMENTAL | Oxycodone 40 mg non-manipulated |
| Name | Type | Description |
|---|---|---|
| PTI-821 capsule Manipulated | DRUG | PTI-821 (oxycodone) 40 mg extended release capsule |
| PTI-821 Non-manipulated | DRUG | PTI-821 (oxycodone) 40 mg capsule extended release capsule |
| OxyContin | DRUG | Crushed OxyContin (oxycodone) extended-release 40 mg tablet |
| Placebo | OTHER | Matching placebos for PTI-821 and oxycodone IR |
| Oxycodone | DRUG | Crushed oxycodone 40 mg immediate release tablet |
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 infor...