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
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Nov 2012
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 14, 2012
CompletedFirst Posted
Study publicly available on registry
November 21, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedDecember 24, 2012
December 1, 2012
1 month
November 14, 2012
December 20, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
AUCinf(dn): Area Under the Curve From Time Zero to Infinity, dose-normalized
72 hours post dose
Cmax(dn): Maximum Observed Plasma Concentration (Cmax), dose normalized
72 hours post dose
Secondary Outcomes (6)
AUClast(dn): Area Under the Curve From Time Zero to Last Quantifiable Concentration, dose normalized
72 hours post dose
AUCinf: Area Under the Curve From Time Zero to Infinity
72 hours post dose
Cmax: Maximum Observed Plasma Concentration
72 hours post dose
AUClast: Area Under the Curve From Time Zero to Last Quantifiable Concentration
72 hours post dose
Tmax: Amount of time drug takes to reach Cmax
72 hours post dose
- +1 more secondary outcomes
Study Arms (2)
Experimental Treatment A
EXPERIMENTALA single dose of 11 mg tofacitinib modified-release (MR) administered in a fasting state.
Experimental Treatment B
EXPERIMENTALA single dose of 22 mg tofacitinib modified-release (MR) administered in a fasting state.
Interventions
A single dose of 11 mg tofacitinib modified-release (MR) administered in a fasting state.
Eligibility Criteria
You may qualify if:
- Healthy male subjects and/or healthy female subjects who are of non-childbearing potential.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
Singapore, Singapore, 188770, Singapore
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2012
First Posted
November 21, 2012
Study Start
November 1, 2012
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
December 24, 2012
Record last verified: 2012-12