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 is an investigational small molecule being studied by Pfizer, Inc. (PFE). It refers to the crushed form of ALO-02 capsules, which was evaluated in a Phase 1 clinical trial to characterize its abuse liability in healthy, non-dependent, recreational opioid users. The study has been completed.
Crushed ALO-02 was studied in healthy, non-dependent, recreational opioid users to characterize its abuse liability when the capsules are crushed and snorted. The Phase 1 trial enrolled 45 participants in Canada and has been completed.
Crushed ALO-02 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The Phase 1 clinical trial for crushed ALO-02 has been completed.
Crushed ALO-02 is in Phase 1 clinical development. The Phase 1 trial, which evaluated the abuse liability of crushed and snorted ALO-02 capsules in healthy recreational opioid users, has been completed. Crushed ALO-02 is investigational and not approved.
Crushed ALO-02 was studied in one completed Phase 1 clinical trial, NCT01775189. The study, conducted in Canada, enrolled 45 healthy, non-dependent, recreational opioid users and was placebo-controlled, randomized, and double-blind. The trial has been completed.