Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-05089771 · 8 trials · 4 indications
The endpoint average pain score, based on the mean of the last 7 days' daily pain numeric rating scale (NRS) scores at (NRS is an 11-point scale where 0 = no pain and 10 = worst possible pain) from the daily pain diaries while receiving study medication during the treatment period.
Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10, where 0= no pain and 10= worst possible pain; higher scores signify more pain. The average pain score was calculated as the mean of the pain scores recorded every 15 minutes from 0 to 4 hours post-dose.
TOTPAR(6) was defined as the total area under pain relief (PR) curve through first 6 hours after dosing, calculated using trapezoidal rule. PR was assumed to be 0 at 0 hour. PR assessed on a 5-point categorical scale: 0(none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at different time points during study up to 6 hours. Total score range for TOTPAR(6): 0 (worst) to 24 (best), higher value indicated greater degree of PR. Posterior mean, standard deviation were estimated based on analysis of covariance (ANCOVA) model with non-informative priors within outlier robust Bayesian framework.
| Arm | Type | Description |
|---|---|---|
| PF-05089771 | EXPERIMENTAL | - |
| Placebo | EXPERIMENTAL | - |
| Pregabalin | EXPERIMENTAL | - |
| PF-05089771 + Pregabalin | EXPERIMENTAL | - |
| PF-05089771 1600 mg | EXPERIMENTAL | - |
| Placebo comparator: matching placebo | PLACEBO_COMPARATOR | Single oral dose of placebo for PF-05089771 1600 mg |
| PF-05089771 450 mg | EXPERIMENTAL | - |
| PF-05089771 150 mg | EXPERIMENTAL | - |
| Ibuprofen 400 mg | ACTIVE_COMPARATOR | - |
| PF-05089771 Oral Dispersion fasted | EXPERIMENTAL | Oral dispersion TS formulation- fasted |
| PF-05089771 TS formulation fasted | EXPERIMENTAL | Capsules TS formulation- fasted |
| PF-05089771 TS formulation fed | EXPERIMENTAL | Tablets TS formulation- fed |
| Cohort 1: Experimental intervention: PF-05089771 or placebo | EXPERIMENTAL | Subjects will receive multiple doses of PF-05089771 or placebo twice daily to investigate the safety/tolerability and Pharmacokinetics (PK) of PF-05089771. |
| Cohort 2: Experimental intervention: PF-05089771 or placebo | EXPERIMENTAL | Subjects will receive multiple doses of PF-05089771 or placebo twice daily to investigate the safety/tolerability and PK of PF-05089771. |
| Cohort 3: Experimental intervention: PF-05089771 or placebo | EXPERIMENTAL | Subjects with osteoarthritis of the knee will receive multiple doses of PF-05089771 or placebo twice daily to investigate the safety/tolerability and Pharmacokinetic (PK) of PF-05089771. |
| Cohort 4: Experimental intervention: PF-05089771 or placebo | EXPERIMENTAL | Elderly Subjects will receive multiple doses of PF-05089771 or placebo twice daily to investigate the safety/tolerability and Pharmacokinetic (PK) of PF-05089771. |
| Cohort 5: Experimental intervention: PF-05089771 or placebo | EXPERIMENTAL | Subjects will receive multiple doses of PF-05089771 or placebo twice daily to investigate the safety/tolerability and PK of PF-05089771. |
| Cohort 1 PF-05089771 or placebo | EXPERIMENTAL | Subjects will receive multiple doses of PF-05089771 or placebo twice daily to investigate the safety/tolerability and PK of PF-05089771. The PK of alternative formulations of PF-05089771 and the effect of food on PK may also be investigated. |
| Cohort 2 PF-05089771 or placebo | EXPERIMENTAL | Subjects will receive multiple doses of PF-05089771 or placebo twice daily to investigate the safety/tolerability and PK of PF-05089771. The PK of alternative formulations of PF-05089771 and the effect of food on PK may also be investigated. |
| Cohort 3 PF-05089771 or placebo | EXPERIMENTAL | Subjects will receive multiple doses of PF-05089771 or placebo either twice or thrice daily to investigate the safety/tolerability and PK of PF-05089771. The PK of alternative formulations of PF-05089771 and the effect of food on PK may also be investigated. |
| Cohort 4 PF-05089771 or placebo | EXPERIMENTAL | Subjects will receive multiple doses of PF-05089771 or placebo either twice or thrice daily to investigate the safety/tolerability and PK of PF-05089771. The PK of alternative formulations of PF-05089771 and the effect of food on PK may also be investigated. |
| Cohort 6: Experimental intervention: PF-05089771 or placebo | EXPERIMENTAL | Cohort 6 |
| Name | Type | Description |
|---|---|---|
| PF-05089771 150 mg | DRUG | PF-05089771 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks. |
| Matched placebo for PF-05089771 150 mg and pregabalin 300 mg | DRUG | Matched placebo for PF-05089771 150 mg twice daily and pregabalin 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks. |
| Pregabalin 300 mg | DRUG | Pregabalin 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks. |
| PF-05089771 150 mg + Pregabalin 300 mg | DRUG | PF-05089771 150 mg twice daily oral capsules with pregabalin 150 mg twice daily oral capsules. Treatment period = 4 weeks. |
| PF-05089771 | DRUG | A single oral dose of PF-05089771 1600 mg solution to be administered on Day 1 of each treatment session. There are 2 treatment sessions, therefore 2 single oral doses of PF-05089771 will be adminstered. |
| Placebo | DRUG | Placebo for PF-05089771 1600 mg solution administered in each treatment session. There are 2 treatment sessions, therefore 2 single oral doses of placebo will be administered. |
| Ibuprofen | DRUG | 2 X 200 mg tablets of ibuprofen administered orally once to the subject on Day 1 postoperatively |
Inclusion Criteria: * Men and women aged 18 years to 80 years. * Diagnosis of Type 2 diabetes mellitlus (T2DM) with current glycosylated hemoglobin A1c (HbA1c) levels of ≤ 11% at Screening and on a stable antidiabetic medication regimen for at least 30 days prior to randomization. * Presence of ong...
PF-05089771 is an investigational small molecule developed by Pfizer for the treatment of pain. It has been studied in Phase 2 clinical trials for painful diabetic peripheral neuropathy, inherited erythromelalgia, and postoperative dental pain. It is not approved and remains in clinical development.
PF-05089771 targets SCN9A, the gene encoding the Nav1.7 sodium channel. It acts as a blocker of this target. By blocking Nav1.7, the drug is designed to reduce pain signaling, which is why it has been studied in neuropathic and other pain conditions.
PF-05089771 is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the clinical trials evaluating the compound in pain indications, including painful diabetic peripheral neuropathy and inherited erythromelalgia.
PF-05089771 is in Phase 2 development. Five clinical trials have been completed, including Phase 1 pharmacokinetic studies and Phase 2 efficacy studies, and no trials are currently active. The drug is investigational and has not been approved for any indication.
Completed trials include NCT02215252, a Phase 2 study of PF-05089771 alone and with pregabalin in painful diabetic peripheral neuropathy, and NCT01769274, a Phase 2 study in inherited erythromelalgia. Phase 1 studies NCT01690351 and NCT01563497 compared capsule, tablet, and oral dispersion formulations in healthy volunteers.