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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

Last updated on December 5, 2019

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Study Location
Pfizer Investigational Site
Singapore, , 188770 Singapore
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male subjects and/or healthy females subjects who are of non-childbearing
potential.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease;

- Clinically significant infections within the past 3 months

NCT01499004
Pfizer
Completed
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

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Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE A Phase 1, Randomized, Open Label, Partial Crossover Study To Evaluate The Pharmacokinetics (PK) And Safety Of Three Modified Release (MR) And One Immediate Release (IR) Formulations Of Tofacitinib (CP-690,550) In Healthy Volunteers
Brief SummaryThis study will explore the drug behavior and safety following a single dose of three different 22 milligram tofacitinib (CP-690,550) modified-release formulations in 30 healthy volunteers. These formulations will be compared to 10 milligram tofacitinib (CP-690-550) in an immediate-release formulation.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: tofacitinib (CP-690,550) modified-release formulation A
    A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation A administered with food.
  • Drug: tofacitinib (CP-690,550) modified-release formulation B1
    A single dose of 22 mg tofacitinib (CP-690,550) MR-B1 formulation administered with food
  • Drug: tofacitinib (CP-690,550) modified-release formulation A
    A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation A administered without food
  • Drug: tofacitinib (CP-690,550) modified-release formulation B1
    A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation B1 administered without food
  • Drug: tofacitinib (CP-690,550) modified-release formulation B2
    A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation B2 administered without food
  • Drug: tofacitinib (CP-690,550) immediate-release formulation
    A single dose of 10 mg tofacitinib (CP-690,550) immediate-release formulation administered without food
Study Arms  ICMJE
  • Experimental: Treatment A
    tofacitinib (CP-690,550) modified-release formulation A-Fed
    Intervention: Drug: tofacitinib (CP-690,550) modified-release formulation A
  • Experimental: Treatment B
    tofacitinib (CP-690,550) modified-release formulation B1-Fed
    Intervention: Drug: tofacitinib (CP-690,550) modified-release formulation B1
  • Experimental: Treatment C
    tofacitinib (CP-690,550) modified-release formulation A-Fasted
    Intervention: Drug: tofacitinib (CP-690,550) modified-release formulation A
  • Experimental: Treatment D
    tofacitinib (CP-690,550) modified-release formulation B1-Fasted
    Intervention: Drug: tofacitinib (CP-690,550) modified-release formulation B1
  • Experimental: Treatment E
    tofacitinib (CP-690,550) modified-release formulation B2-Fasted
    Intervention: Drug: tofacitinib (CP-690,550) modified-release formulation B2
  • Experimental: Treatment F
    tofacitinib (CP-690,550) immediate-release formulation-Fasted
    Intervention: Drug: tofacitinib (CP-690,550) immediate-release formulation
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 21, 2011)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion DateDecember 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 allergic disease;
  • Clinically significant infections within the past 3 months
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 21 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01499004
Other Study ID Numbers  ICMJE A3921131
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJanuary 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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