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Also known as PTI-821 capsule Manipulated, PTI-821 Manipulated, PTI-821 Non-manipulated
PTI-821 · 1 trial · 1 indication
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...
PTI-821 is an investigational small molecule developed by Filana Therapeutics, Inc. for opioid abuse nondependent, a pain-related therapeutic area. It has been studied in a Phase 1 human abuse potential trial. PTI-821 is not approved and remains in clinical development.
PTI-821 is being developed for opioid abuse nondependent within the pain therapeutic area. Its only recorded clinical trial evaluated nasal human abuse potential in healthy volunteers. The drug is investigational and has not been approved for any use.
PTI-821 is developed by Filana Therapeutics, Inc., which trades under the ticker FLNA. The company is the sponsor of the Phase 1 trial of PTI-821.
PTI-821 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are ongoing. The drug is investigational and has not received FDA approval.
PTI-821 has been studied in one completed Phase 1 trial, NCT03475862, titled Nasal Human Abuse Potential of PTI-821. It enrolled 38 healthy volunteers in the United States, was randomized, double-blind, and placebo-controlled. No active trials are ongoing.
Yes, PTI-821 capsule Manipulated, PTI-821 Manipulated, and PTI-821 Non-manipulated are alternative names for PTI-821. These refer to different forms or manipulations of the same investigational drug developed by Filana Therapeutics, Inc.