Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04338711 | A Study In Adult Healthy Volunteers To Asses Once Daily (QD) Dosing With The Selected Age-Appropriate Modified Release (MR) Formulations | PHASE1 | COMPLETED | 23 | — | — | Jun 17, 2020 | Sep 15, 2020 | Oct 29, 2020 | 1 | United States |
| NCT02084875 | A Study To Evaluate The Effect Of Food On The Behavior Of Tofacitinib Modified Release 11 Milligram Tablets In Healthy Western And Japanese Volunteers | PHASE1 | COMPLETED | 24 | — | — | Apr 11, 2014 | May 25, 2014 | Nov 30, 2018 | 1 | United States |
| NCT01731327 | A Phase 1 Study To Evaluate The Pharmacokinetics (PK), Safety, And Bioavailability Of A Modified-Release (MR) Formulation Of Tofacitinib In Healthy Volunteers | PHASE1 | COMPLETED | 20 | — | — | Nov 1, 2012 | Dec 1, 2012 | Dec 24, 2012 | 1 | Singapore |
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...