Co-Administration Of Methotrexate And CP-690,550

Part of paid clinical trials in Daytona Beach, Florida.

Sponsor
Pfizer
Study ID
NCT01745055
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • CP-690,550 (tofacitinib) — DRUG
    CP-690,550 30 mg q12h for 5 days
  • Methotrexate (MTX) — DRUG
    individual dose of methotrexate (stably dosed)

Study Details

This study was designed to estimate the effects of methotrexate (MTX) on the pharmacokinetics (PK) of CP-690,550 when administered to subjects with rheumatoid arthritis (RA), to estimate the effects of CP-690,550 on the PK of MTX and to evaluate the short-term safety and tolerability of co-administration of CP-690,550 and MTX.

Key Dates

Start date
Apr 30, 2005
Status verified
Jan 2013
Primary completion
Jun 30, 2006
Completion
Jun 30, 2006

Study Design

Enrollment
12 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: CP-690,550 (tofacitinib) 30 mg q12h
    Individual dose of methotrexate with the addition of CP-690,550 30 mg q12h

Primary Outcome Measure

Area Under the Curve From Time Zero to 12 Hours [AUC (0-12)] for CP-690,550 [ Time Frame: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8 and 12 hours post-dose on Day 6 and Day 7 ]

Locations (4)

FacilityCityStateZIPSite coordinators
Pfizer Investigational SiteDaytona BeachFlorida32114-
Pfizer Investigational SiteFort LauderdaleFlorida33301-
Pfizer Investigational SiteMiramarFlorida33025-
Pfizer Investigational SiteDallasTexas75247-

Find similar trials in Daytona Beach, FL

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Pfizer Investigational Site· Daytona Beach, FLPfizer Investigational Site· Fort Lauderdale, FLPfizer Investigational Site· Miramar, FLPfizer Investigational Site· Dallas, TX

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