Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
intact ALO-02 · 1 trial · 1 indication
Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the extreme left with "strong disliking" (score of 0 mm) and on the extreme right with "strong liking" (score of 100 mm). Peak Effect (Emax) = Maximum observed score.
Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the extreme left with "strong disliking" (score of 0 mm) and on the extreme right with "strong liking" (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours.
High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours.
| Arm | Type | Description |
|---|---|---|
| Treatment A | PLACEBO_COMPARATOR | - |
| Treatment B | EXPERIMENTAL | - |
| Treatment C | EXPERIMENTAL | - |
| Treatment D | ACTIVE_COMPARATOR | - |
| Treatment E | EXPERIMENTAL | - |
| Treatment F | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo solution + Placebo ALO-02 (intact) |
| intact ALO-02 60 mg/7.2 mg | DRUG | Placebo solution + ALO-02 60 mg/7.2 mg (intact) |
| crushed ALO-02 60 mg/7.2 mg | DRUG | crushed ALO-02 60 mg/7.2 mg in solution + placebo ALO-02 (intact) |
| crushed oxycodone IR 60 mg | DRUG | crushed oxycodone immediate-release (IR) 60 mg in solution + placebo ALO-02 (intact) |
| crushed ALO-02 40 mg/4.8 mg | DRUG | crushed ALO-02 40 mg/4.8 mg in solution + placebo ALO-02 (intact) |
| crushed oxycodone IR 40 mg | DRUG | crushed oxycodone immediate-release (IR) 40 mg in solution + placebo ALO-02 (intact) |
Inclusion Criteria: * Healthy subjects. * Non-dependent, recreational opioid users. (Must use opioid for non-therapeutic purposes on at least 10 occassions within the last year before Screening Visit, and at least once in 8 weeks before the Screening Visit. Exclusion Criteria: * Diagnosis of subs...
intact ALO-02 is an investigational small molecule developed by Pfizer, Inc. (ticker PFE). It has been studied in a Phase 1 clinical trial in healthy volunteers, specifically to characterize its abuse liability in non-dependent recreational opioid abusers. The drug is not approved and remains in clinical development.
intact ALO-02 is being developed by Pfizer, Inc., which trades under the ticker symbol PFE. Pfizer sponsored the Phase 1 trial that evaluated the drug's abuse liability profile in healthy, non-dependent recreational opioid abusers.
intact ALO-02 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are ongoing. The drug has not been approved by the FDA and remains investigational.
intact ALO-02 has been evaluated in one completed Phase 1 trial, NCT01746901, titled "A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Abusers." The trial enrolled 81 participants in Canada and was randomized, double-blind, and placebo-controlled.