Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
tofacitinib modified release · 3 trials · 1 indication
Area Under the Curve From Time Zero to Extrapolated Infinite Time \[AUC (0 - ∞)\]
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) of Modified Release (MR) formulation compared to Immediate Release (IR) solution
Maximum (or peak) plasma concentration of MR formulation compared to IR solution
Maximum time to peak plasma concentration of MR formulation compared to IR solution
| Arm | Type | Description |
|---|---|---|
| Treatment A | EXPERIMENTAL | Single oral 10 mg dose of tofacitinib MR E1 administered in the fasted state. |
| Treatment B | EXPERIMENTAL | Single oral 10 mg dose of tofacitinib MR E2 administered in the fasted state. |
| Treatment C | EXPERIMENTAL | Single oral 10 mg dose of tofacitinib MR E3 administered in the fasted state. |
| Treatment D | EXPERIMENTAL | Single oral 10 mg dose of tofacitinib MR E1 administered in the fed state. |
| Treatment E | EXPERIMENTAL | Single oral 10 mg dose of tofacitinib MR E3 administered in the fed state. |
| Treatment F | ACTIVE_COMPARATOR | Single oral 10 mg dose of tofacitinib IR Solution (10 mL of the 1 mg/mL solution) administered in the fasted state. |
| tofacitinib MR 11 mg Fed | EXPERIMENTAL | tofacitinib modified release (MR) 11 mg tablet administered with food. |
| tofacitinib MR 11 mg Fasting | EXPERIMENTAL | tofacitinib modified release (MR) 11 mg tablet administered without food. |
| Experimental Treatment A | EXPERIMENTAL | A single dose of 11 mg tofacitinib modified-release (MR) administered in a fasting state. |
| Experimental Treatment B | EXPERIMENTAL | A single dose of 22 mg tofacitinib modified-release (MR) administered in a fasting state. |
| Name | Type | Description |
|---|---|---|
| tofacitinib modified release (MR) | DRUG | Single oral 10 mg multi particulate dose of dose of tofacitinib MR with different levels of enteric coating (MR E1, MR E2, and MR E3) in the fasted state. Additionally, the lowest and highest enteric coating levels will also be evaluated in the fed state. Treatment F: a 10 mg oral dose of tofacitinib IR solution |
| tofacitinib modified-release (MR) formulation | DRUG | A single dose of tofacitinib modified release 11 mg tablet after receiving the standard FDA high fat/high calorie meal. |
Inclusion Criteria: * Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive. * Female subjects of non-childbearing potential must meet at least 1 of the following criteria: 1. . Achieved postmenopausal status, defined as: cessation of re...
Tofacitinib modified release is an investigational small molecule being studied in healthy volunteers. It is a modified-release formulation of tofacitinib, and the Phase 1 trials evaluate its pharmacokinetics, safety, bioavailability, and the effect of food on its behavior. It is not approved and remains in clinical development.
Tofacitinib modified release is being developed by Pfizer, Inc., traded on the New York Stock Exchange under the ticker PFE. Pfizer is conducting Phase 1 clinical trials of this modified-release formulation in healthy volunteers.
Tofacitinib modified release is in Phase 1 clinical development. All three completed trials are Phase 1 studies in healthy volunteers, and the drug is investigational, not FDA approved.
Tofacitinib modified release has three completed Phase 1 trials: NCT01731327 in Singapore, NCT02084875 in the United States, and NCT04338711 in the United States. These studies enrolled a total of 67 healthy volunteers and evaluated pharmacokinetics, safety, bioavailability, food effects, and once-daily dosing.
Tofacitinib modified release is a modified-release formulation of tofacitinib, designed for once-daily dosing. The clinical trials compare it to other formulations of tofacitinib, but it is a distinct dosage form being studied separately in healthy volunteers.