Tofacitinib Bioequivalence Study Comparing Tablets And Capsules

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01599377
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 2
• Patients Per Site Per Month: 24.9

Study Details

Study Description

Brief Summary

The overall aim of the study is to establish bioequivalence between commercial tofacitinib tablet formulations with the tofacitinib capsule formulation.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: tofacitinib 10 mg; Drug: tofacitinib 5 mg	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• 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
• Study Start Date: May 1, 2012
• Actual Primary Completion Date: Jul 1, 2012
• Actual Study Completion Date: Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1	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.
Experimental: Cohort 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.

Outcome Measures

Primary Outcome Measures

1. Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf ) [24 hours]

2. Maximum plasma concentration (Cmax) [24 hours]

Secondary Outcome Measures

1. Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast) [24 hours]

2. Time for Cmax (Tmax) [24 hours]

3. Terminal elimination half-life (t½) [24 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Singapore		Singapore	188770

Sponsors and Collaborators

• Pfizer

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01599377
• Other Study ID Numbers: A3921141
• First Posted: May 16, 2012
• Last Update Posted: Jul 10, 2012
• Last Verified: Jul 1, 2012

• Additional relevant MeSH terms: Tofacitinib

Study Results

No Results Posted as of Jul 10, 2012