Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ALO-01 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | 2 Placebo capsules (whole) + ALO-01 2 x 60 mg capsules (crushed) in apple juice + apple juice (MSIR placebo) |
| B | EXPERIMENTAL | 2 x 60 mg ALO-01 (whole) + 2 x placebo capsules (crushed) in apple juice + apple juice (MSIR placebo) |
| C | ACTIVE_COMPARATOR | 2 x placebo capsules (whole) + 2 X placebo capsules (crushed) in apple juice + 120 mg MSIR in apple juice |
| D | PLACEBO_COMPARATOR | 2 x placebo capsules (whole) + 2 X placebo capsules (crushed) in apple juice + apple juice (MSIR placebo) |
| Name | Type | Description |
|---|---|---|
| ALO-01 | DRUG | ALO-01 capsules |
| MSIR | DRUG | immediate release morphine sulfate |
| Placebo | DRUG | Placebo |
Inclusion Criteria: * Male or female subjects 18 to 55 years of age, inclusive. * Subjects had to be opioid users who were not currently physically dependent on opioids (based on DSM-IV criteria) but had experience in the use of opioids for non-therapeutic purposes (i.e. for psychoactive effects) o...
ALO-01 is an investigational small molecule being developed by Pfizer, Inc. (NYSE: PFE). It is currently in Phase 1 clinical development. ALO-01 has been studied in healthy volunteers, and it is not approved by the FDA. It remains an investigational drug in clinical trials.
ALO-01 is being studied for use in healthy volunteers. The completed Phase 1 trial evaluated its bioavailability, pharmacodynamic effects, and safety compared to morphine sulfate immediate release (MSIR). The drug is not approved for any indication and is still in early clinical development.
Pfizer, Inc. (NYSE: PFE) is developing ALO-01. The company conducted a Phase 1 clinical trial of the drug in healthy volunteers. Pfizer is the sponsor of the investigational small molecule, which is not yet approved.
ALO-01 is in Phase 1 clinical development. A single Phase 1 trial has been completed, and there are no active trials currently listed. The drug is investigational and has not been approved by regulatory authorities.
ALO-01 has one completed Phase 1 trial, NCT00751478, titled "Study to Determine the Bioavailability, Pharmacodynamic Effects, and Safety of Whole and Crushed ALO-01 Compared to Morphine Sulfate Immediate Release (MSIR)." The trial enrolled 32 healthy volunteers in Canada and was randomized, double-blind, and placebo-controlled.
ALO-01 is not the same as morphine. In the Phase 1 trial, ALO-01 was compared to morphine sulfate immediate release (MSIR) to evaluate its bioavailability, pharmacodynamic effects, and safety. ALO-01 is a separate investigational drug being developed by Pfizer.