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A Phase 1 Study To Evaluate The Pharmacokinetics (PK), Safety, And Bioavailability Of A Modified-Release (MR) Formulation Of Tofacitinib In Healthy Volunteers

Last updated on December 16, 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 female 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

NCT01731327
Pfizer
Completed
A Phase 1 Study To Evaluate The Pharmacokinetics (PK), Safety, And Bioavailability Of A Modified-Release (MR) Formulation Of Tofacitinib In Healthy Volunteers

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A Phase 1 Study To Evaluate The Pharmacokinetics (PK), Safety, And Bioavailability Of A Modified-Release (MR) Formulation Of Tofacitinib In Healthy Volunteers
A Phase 1, Randomized, Open-Label, 2-Way Crossover Study To Evaluate The Pharmacokinetics (PK), Safety, And Bioavailability Of Tofacitinib Following Single Oral Dose Of MR 11 mg Compared To MR 22 mg In Healthy Volunteers
This study will explore the drug behavior and safety following single doses of tofacitinib modified-release (MR) 11 mg and MR 22 mg in healthy volunteers.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
  • Drug: tofacitinib modified-release (MR) formulation
    A single dose of 11 mg tofacitinib modified-release (MR) administered in a fasting state.
  • Drug: tofacitinib modified-release (MR) formulation
    A single dose of 22 mg tofacitinib modified-release (MR) administered in a fasting state.
  • Experimental: Experimental Treatment A
    A single dose of 11 mg tofacitinib modified-release (MR) administered in a fasting state.
    Intervention: Drug: tofacitinib modified-release (MR) formulation
  • Experimental: Experimental Treatment B
    A single dose of 22 mg tofacitinib modified-release (MR) administered in a fasting state.
    Intervention: Drug: tofacitinib modified-release (MR) formulation
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2012
December 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male subjects and/or healthy female 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
 
 
NCT01731327
A3921132
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2012

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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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1-800-718-1021

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Contact

[email protected]



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