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PF-04531083 · 3 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Randomized cross-over sequence | OTHER | Randomized unbalanced sequence of incomplete block design with replicates within sequence |
| Cohort 1: PF-04531083 | ACTIVE_COMPARATOR | - |
| Cohort 2: PF-04531083 | ACTIVE_COMPARATOR | - |
| cohort 1 | EXPERIMENTAL | - |
| cohort 2 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| PF-04531083 100mg | DRUG | Oral PF-04531083 100mg suspension single dose |
| PF-04531083 2000mg | DRUG | Oral PF-04531083 2000mg suspension single dose |
| Placebo suspension | DRUG | Oral Placebo suspension (matched to PF-04531083 suspension) |
| Placebo tablet | DRUG | Oral Placebo tablet (matched to Oxycodone) |
| Oxycodone 20mg | DRUG | Oral Oxycodone 20mg (Oxycontin) controlled release formulation |
| PF-04531083 | DRUG | Dosed as a tablet in 100mg strengths. Dosage in the first cohort will be 300mg twice daily for 3 days followed by 200mg twice daily for 11 days |
| simvastatin | DRUG | Simvastatin: a single 20mg tablet to be given on Days 1 and 14 of the study. |
Inclusion Criteria: * Healthy volunteers. * Body mass index between 17.5 - 30.5 kg/m2 and body weight greater than 50 kg. Exclusion Criteria: * Subjects that have any condition possibly affecting drug absorption (eg, gastrectomy). * Treatment with an investigational drug within 30 days (or as det...
PF-04531083 is an investigational small molecule being developed by Pfizer for chronic pain. It has been studied in healthy volunteers and in the context of chronic pain, with completed Phase 1 trials assessing its effects on drug interactions, tablet formulation performance, and heat pain response.
PF-04531083 is being developed by Pfizer, Inc., which trades under the ticker PFE. The drug is a small molecule in Phase 1 clinical development for pain-related indications.
PF-04531083 is in Phase 1 clinical development. All three of its clinical trials have been completed, with a total enrollment of 48 participants across studies conducted in Belgium.
PF-04531083 has been studied in three completed Phase 1 trials: NCT01103739, which explored its effect on simvastatin blood concentrations; NCT01119235, which observed tablet formulation performance; and NCT01127906, which assessed its effect on heat pain in healthy volunteers.
PF-04531083 is not FDA approved. It is an investigational drug that has completed Phase 1 clinical trials for chronic pain and related conditions, but it remains in clinical development and has not been approved for any use.