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tofacitinib modified-release formulation A · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Treatment A | EXPERIMENTAL | tofacitinib (CP-690,550) modified-release formulation A-Fed |
| Treatment B | EXPERIMENTAL | tofacitinib (CP-690,550) modified-release formulation B1-Fed |
| Treatment C | EXPERIMENTAL | tofacitinib (CP-690,550) modified-release formulation A-Fasted |
| Treatment D | EXPERIMENTAL | tofacitinib (CP-690,550) modified-release formulation B1-Fasted |
| Treatment E | EXPERIMENTAL | tofacitinib (CP-690,550) modified-release formulation B2-Fasted |
| Treatment F | EXPERIMENTAL | tofacitinib (CP-690,550) immediate-release formulation-Fasted |
| Name | Type | Description |
|---|---|---|
| tofacitinib (CP-690,550) modified-release formulation A | DRUG | A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation A administered with food. |
| tofacitinib (CP-690,550) modified-release formulation B1 | DRUG | A single dose of 22 mg tofacitinib (CP-690,550) MR-B1 formulation administered with food |
| tofacitinib (CP-690,550) modified-release formulation B2 | DRUG | A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation B2 administered without food |
| tofacitinib (CP-690,550) immediate-release formulation | DRUG | A single dose of 10 mg tofacitinib (CP-690,550) immediate-release formulation administered without food |
Inclusion Criteria: * Healthy male subjects and/or healthy females subjects who are of non-childbearing potential. Exclusion Criteria: * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or...
Tofacitinib modified-release formulation A is an experimental oral small molecule developed by Pfizer, Inc. (NYSE: PFE). It is a modified-release version of tofacitinib, also known as CP-690,550, designed to release the drug differently than the immediate-release form. It has been studied in a Phase 1 pharmacokinetics and safety trial in healthy volunteers.
Tofacitinib modified-release formulation A targets the Janus kinases JAK3, JAK1, JAK2, and TYK2. It acts as an inhibitor of these enzymes. By inhibiting JAK family kinases, the compound interferes with signaling pathways that depend on JAK activity.
Pfizer, Inc. (ticker PFE) is the developer of tofacitinib modified-release formulation A. Pfizer also developed the related immediate-release tofacitinib formulation.
Tofacitinib modified-release formulation A is in Phase 1 development. It is investigational and has not been approved by the FDA. The single recorded trial, NCT01499004, has been completed, and no active trials of this formulation are listed.
Tofacitinib modified-release formulation A has been evaluated in one completed Phase 1 trial, NCT01499004. That study assessed the pharmacokinetics and safety of three modified-release formulations and one immediate-release formulation of tofacitinib (CP-690,550) in 30 healthy volunteers in Singapore. It was randomized and controlled, with participants aged 21 years and older.
Yes. Tofacitinib modified-release formulation A is also known as tofacitinib (CP-690,550) modified-release formulation A. CP-690,550 is the compound identifier for tofacitinib, so both names refer to the same modified-release formulation developed by Pfizer.