Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-05089771 · 11 trials · 5 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 300 mg | EXPERIMENTAL | - |
| PF-05089771 300 mg + pregabalin 300 mg | EXPERIMENTAL | - |
| pregabalin 300 mg | ACTIVE_COMPARATOR | - |
| ibuprofen 600 mg | ACTIVE_COMPARATOR | - |
| Oral disperion fasted | EXPERIMENTAL | A single dose of 450 mg PF-05089771 TS oral dispersion in fasted conditions. |
| Capsule fasted | EXPERIMENTAL | single dose of 450 mg PF-05089771 TS as 3 x 150 mg capsules in fasted conditions |
| Capsule fed | EXPERIMENTAL | single dose of 450 mg PF-05089771 TS as 3 x 150 mg capsules in fed conditions |
| Arm A - active treatment | EXPERIMENTAL | - |
| Arm B - placebo | PLACEBO_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 |
| PF-05089771 300mg | DRUG | PF-05089771 300 mg |
| PF-05089771 300 mg + pregabalin 300 mg | DRUG | PF-05089771 300 mg + pregabalin 300 mg |
| ibuprofen 600 mg | DRUG | ibuprofen 600 mg |
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 being studied for painful diabetic neuropathy, inherited erythromelalgia, postoperative dental pain, and pain in healthy volunteers. It is being developed by Pfizer, Inc. (PFE) and is currently in Phase 2 clinical development.
PF-05089771 is a small molecule that targets the Nav1.7 sodium channel, which plays a role in pain signaling. By modulating this channel, the drug aims to reduce pain transmission. Pfizer is investigating it for conditions such as painful diabetic neuropathy and inherited erythromelalgia.
PF-05089771 is being developed by Pfizer, Inc., a pharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 2 clinical trials for pain-related indications.
PF-05089771 is in Phase 2 clinical development. It has completed five clinical trials, including Phase 1 and Phase 2 studies. The drug is investigational and has not been approved by regulatory authorities for any indication.
PF-05089771 has completed five clinical trials, including NCT01259882, NCT01529671, NCT01690351, and NCT02215252. These studies evaluated the drug in healthy volunteers and patients with pain conditions, including a Phase 2 trial for painful diabetic neuropathy.
PF-05089771 is a unique investigational compound developed by Pfizer. It is not known to have alternative names or be the same as other marketed drugs. It is being studied as a potential treatment for various pain conditions.