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tofacitinib modified-release formulation A

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Jan 12, 2012

Target and mechanism

ModalitySmall molecule

Also known as tofacitinib (CP-690,550) modified-release formulation A

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

tofacitinib modified-release formulation A · 1 trial · 1 indication

Phase 1 1
NCT01499004A Phase 1 Study To Evaluate The Pharmacokinetics And Safety Of Three Modified Release And One Immediate Release Formulations Of Tofacitinib (CP-690,550) In Healthy VolunteersHealthy
COMPLETED30 Analytics
PHASE1COMPLETED
A Phase 1 Study To Evaluate The Pharmacokinetics And Safety Of Three Modified Release And One Immediate Release Formulations Of Tofacitinib (CP-690,550) In Healthy Volunteers
Healthy
NCT0149900430
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Study Endpoints

Primary Endpoints

AUCinf: Area under the plasma concentration-time profile from time 0 exprapolated to infinite time
72 hours post dose
AUClast: Area under the plasma concentration-time profile from time 0 to the last with quantifiable concentration
72 hours post dose
Cmax: Maximum plasma concentration of tofacitinib (CP-690,550)
72 hours post dose
Tmax: Amount of time tofacitinib (CP-690,550) is at maximum plasma concentration
72 hours post dose
t1/2: The time required for one half of the total amount of tofacitinib (CP-690,550) to be removed from the plasma
72 hours post dose

Secondary Endpoints

Frel: Relative bioavailability (Frel) of tofacitinib (CP-690,550) in the modified-release formulations compared to the immediate release formulation
24 hours post dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Treatment AEXPERIMENTALtofacitinib (CP-690,550) modified-release formulation A-Fed
Treatment BEXPERIMENTALtofacitinib (CP-690,550) modified-release formulation B1-Fed
Treatment CEXPERIMENTALtofacitinib (CP-690,550) modified-release formulation A-Fasted
Treatment DEXPERIMENTALtofacitinib (CP-690,550) modified-release formulation B1-Fasted
Treatment EEXPERIMENTALtofacitinib (CP-690,550) modified-release formulation B2-Fasted
Treatment FEXPERIMENTALtofacitinib (CP-690,550) immediate-release formulation-Fasted

Interventions

NameTypeDescription
tofacitinib (CP-690,550) modified-release formulation ADRUGA single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation A administered with food.
tofacitinib (CP-690,550) modified-release formulation B1DRUGA single dose of 22 mg tofacitinib (CP-690,550) MR-B1 formulation administered with food
tofacitinib (CP-690,550) modified-release formulation B2DRUGA single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation B2 administered without food
tofacitinib (CP-690,550) immediate-release formulationDRUGA single dose of 10 mg tofacitinib (CP-690,550) immediate-release formulation administered without food
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Eligibility Criteria

Age Range21 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:Singapore
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