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Completed

NCT Number: NCT01745055

Co-Administration Of Methotrexate And CP-690,550

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Daytona Beach, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults diagnosed with moderate to severe RA (Rheumatoid Arthritis)
  • Diagnosis of RA based on the American College of Rheumatology 1987 revised criteria.
  • Treatment with an oral stable weekly dose of Methotrexate (MTX) (15-25 mg/week, administered as a single dose [SD]) for a minimum of 4 doses (4 weeks)

Exclusion criteria

  • Blood dyscrasias including confirmed: Hemoglobin <9 g/dL or Hematocrit <30%; White blood cell count <3.0 x 109/L; Absolute neutrophil count <1.2 x 109/L; Platelet count <100 x 109/L
  • Evidence or history of clinically significant infections within the past 6 months (eg, those requiring hospitalization, requiring parenteral antimicrobial therapy, or those with recurrent oral or genital herpes, recurrent herpes zoster, or any infection otherwise judged by the investigator to have the potential for exacerbation by participation in the trial.
  • Total bilirubin, AST (aspartate aminotransferase) or ALT (alanine aminotransferase) more than 1.2 times the upper limit of normal at the Screening visit, or a history of clinically significant elevated liver function tests (LFTs) while on current MTX dose or chronic liver disease, recent or active hepatitis.

Treatment and study plan

CP-690,550 (tofacitinib)

Drug

CP-690,550 30 mg q12h for 5 days

Methotrexate (MTX)

Drug

individual dose of methotrexate (stably dosed)

Primary outcomes

  1. 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

    AUC (0-12)= area under the plasma concentration time-curve from time zero (pre-dose) to 12 hours (0-12).

  2. Maximum Observed Plasma Concentration (Cmax) 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

  3. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Methotrexate (MTX)

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours post-dose on Day 1 and Day 7

    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).

  4. Maximum Observed Plasma Concentration (Cmax) for Methotrexate (MTX)

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24 and 48 hours post-dose on Day 1 and Day 7

Secondary outcomes

  1. Time to Reach Maximum Observed Plasma Concentration (Tmax) 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

  2. Plasma Decay Half-Life (t1/2) 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

    Plasma decay half-life is the time measured for the plasma concentration of CP-690,550 to decrease by one half.

  3. Apparent Oral Clearance (CL/F) 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

    Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

  4. Time to Reach Maximum Observed Plasma Concentration (Tmax) for Methotrexate (MTX)

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 ,12, 24 and 48 hours post-dose on Day 1 and Day 7

  5. Plasma Decay Half-Life (t1/2) for Methotrexate (MTX)

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 , 12, 24 and 48 hours post-dose on Day 1 and Day 7

    Plasma decay half-life is the time measured for the plasma concentration of MTX to decrease by one half.

  6. Apparent Oral Clearance (CL/F) for Methotrexate (MTX)

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 , 12, 24 and 48 hours post-dose on Day 1 and Day 7

    Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

  7. Total Amount of Unchanged Drug Excreted in the Urine From Time Zero to 12 Hours (Ae[0-12]) for CP-690,550

    Time frame: 0 (pre-dose) through 12 hours post-dose on Day 6 and Day 7

  8. Renal Clearance (CL R) for CP-690,550

    Time frame: 0 (pre-dose) through 24 hours post-dose on Day 6 and Day 7

  9. Total Amount of Unchanged Drug Excreted in the Urine From Time Zero to 24 Hours (Ae[0-24]) for Methotrexate (MTX)

    Time frame: 0 (pre-dose) through 24 hours post-dose on Day 1 and Day 7

  10. Renal Clearance (CL R) for Methotrexate (MTX)

    Time frame: 0 (pre-dose) through 24 hours post-dose on Day 1 and Day 7

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1, Open Label Study Of The Pharmacokinetics Of Multiple Doses Of Oral CP-690,550 And Single Doses Of Oral Methotrexate In Rheumatoid Arthritis Subjects

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Dec 7, 2012
Registry last updated
Feb 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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