Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
crushed 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 | PLACEBO_COMPARATOR | - |
| Treatment D | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| ALO-02 weight-matched placebo | DRUG | crushed sugar spheres (powder) x 1 dose |
| crushed ALO-02 30 mg/3.6 mg | DRUG | crushed ALO-02 30 mg/3.6 mg capsule x 1 dose |
| oxycodone weight-matched placebo | DRUG | crushed lactose tablets (powder) x 1 dose |
| crushed oxycodone IR 30 mg | DRUG | Three (3) crushed immediate-release (IR) oxycodone 10 mg tablets x 1 dose |
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 and at least once in the 8 weeks before Visit 1 (Screening Visit). * Must have experience with intranasal opioid administra...
Crushed ALO-02 refers to the contents of ALO-02 capsules that have been crushed rather than swallowed intact. It is the form studied in a Phase 1 abuse liability trial in healthy, non-dependent recreational opioid users, where participants snorted the crushed material to assess its abuse potential.
ALO-02 is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. The crushed formulation was evaluated in a Pfizer-sponsored Phase 1 study of abuse liability in recreational opioid users.
Crushed ALO-02 has been studied in Phase 1 clinical development. The single recorded trial, NCT01775189, is completed, and no active trials are ongoing. It is an investigational product and has not been approved by the FDA.
Crushed ALO-02 was evaluated in one completed Phase 1 trial, NCT01775189, titled a study to characterize the abuse liability of ALO-02 in healthy, non-dependent, recreational opioid users when ALO-02 capsules are crushed and snorted. The trial enrolled 45 participants in Canada and was randomized, double-blind, and placebo-controlled.
The crushed ALO-02 trial NCT01775189 was a Phase 1, randomized, double-blind, placebo-controlled study in healthy, non-dependent, recreational opioid users aged 18 years and older. It enrolled 45 participants of all sexes in Canada and has been completed.