Tofacitinib Bioequivalence Study Comparing Tablets And Capsules

• ClinicalTrials.gov Identifier: NCT01599377
• Recruitment Status: Completed
• First Posted: May 16, 2012
• Last Update Posted: July 10, 2012
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: May 14, 2012
• First Posted Date: May 16, 2012
• Last Update Posted Date: July 10, 2012
• Study Start Date: May 2012
• Actual Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 14, 2012)

• Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf ) [ Time Frame: 24 hours ]
• Maximum plasma concentration (Cmax) [ Time Frame: 24 hours ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 14, 2012)

• Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast) [ Time Frame: 24 hours ]
• Time for Cmax (Tmax) [ Time Frame: 24 hours ]
• Terminal elimination half-life (t½) [ Time Frame: 24 hours ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Tofacitinib Bioequivalence Study Comparing Tablets And Capsules
• Official Title: Phase 1, Open-Label, Randomized, Single-Dose, Cross-Over, Bioequivalence Study Comparing Tablets (5 And 10 Mg) And Capsules (5 And 10 Mg) Of Tofacitinib Under Fasted Conditions In Healthy Volunteers
• Brief Summary: The overall aim of the study is to establish bioequivalence between commercial tofacitinib tablet formulations with the tofacitinib capsule formulation.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Healthy

Intervention

• Drug: tofacitinib 10 mg
  Cohort 1 will consist of 2 periods and 2 sequences. Subjects will be randomized to one of the 2 sequences. In sequence 1, subjects will receive a 10 mg tofacitnib tablet under fasting conditions in period 1, followed by a 10 mg tofacitinib capsule in fasting conditions in period 2. In sequence 2, the treatments will be reversed for period 1 and 2.
• Drug: tofacitinib 5 mg
  Cohort 2 will consist of 2 periods and 2 sequences. A total of 24 healthy subjects will be enrolled for this cohort. Subjects will be randomized to one of the 2 sequences. In sequence 1, subjects will receive a 5 mg tablet under fasting conditions in period 1, followed by a 5 mg capsule in fasting conditions in period 2. In sequence 2, the treatments will be reversed for period 1 and 2.

Study Arms

• Experimental: Cohort 1
  Intervention: Drug: tofacitinib 10 mg
• Experimental: Cohort 2
  Intervention: Drug: tofacitinib 5 mg

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 8, 2012): 50
• Original Estimated Enrollment (submitted: May 14, 2012): 48
• Actual Study Completion Date: July 2012
• Actual Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Healthy male and/or female (non-childbearing potential) subjects between the ages of 21 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including oral temperature, BP and PR measurement, 12 Lead ECG and clinical laboratory tests.

Exclusion Criteria:

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Singapore

Administrative Information

• NCT Number: NCT01599377
• Other Study ID Numbers: A3921141
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: July 2012