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 being developed by Pfizer, Inc. (PFE). It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers, with one completed trial involving 81 participants.
intact ALO-02 is being studied for use in healthy, non-dependent, recreational opioid abusers. The completed Phase 1 trial aimed to characterize the abuse liability of the drug in this population. It is not approved for any indication and remains in clinical development.
intact ALO-02 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The company conducted a Phase 1 clinical trial to evaluate the drug's abuse liability in healthy volunteers.
intact ALO-02 is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the drug is not currently in active clinical trials.
intact ALO-02 has been studied in one completed Phase 1 clinical trial, NCT01746901. This randomized, double-blind, placebo-controlled study enrolled 81 healthy, non-dependent, recreational opioid abusers in Canada to characterize the drug's abuse liability.