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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 17, 2017

FOR MORE INFORMATION
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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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
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
This 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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2011
December 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
 
NCT01499004
A3921131
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2012

ICMJE     Data element required by the

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

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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