A Study To Compare The Amount Of Tasocitinib (CP-690,550) That Is Absorbed Into The Blood Of Healthy Subjects Following Oral Administration Of Three Different Tablet Versions Of Tasocitinib (CP-690,550)

Phase 1

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C

• Registration Number: NCT01184092
• Lead Sponsor: Pfizer

Brief Summary

In this study, a 10 mg dose of tasocitinib (CP-690,550) will be given to study subjects on three separate occasions using one of three different tablet formulations (tablet versions) each time. The amount of tasocitinib (CP-690,550) available in the blood following administration of each tablet formulation will be measured and compared. The overall aim of the study is to establish that a similar amount of tasocitinib (CP-690,550) is absorbed into the blood following administration of the same dose of each different tablet formulation.

Detailed Description

This is a pivotal bioequivalence study for tasocitinib (CP-690,550).

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-16
• Study First Submitted QC: 2010-08-16
• Study First Posted: 2010-08-18
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-12
• Last Update Posted: 2010-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Healthy male and/or female (non-childbearing potential) subjects between the ages of 21 and 55 years, inclusive.
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight for males>50 kg (110 lbs). For females, total body weight >45 kg (99 lbs).
• No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB).

Exclusion Criteria

• Evidence of any clinically significant illness, medical condition, or disease.
• Evidence or history of any clinically significant infections within the past 3 months.
• Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1	Treatment A	-
Sequence 1	Treatment B	-
Sequence 1	Treatment C	-
Sequence 2	Treatment A	-
Sequence 2	Treatment C	-
Sequence 2	Treatment B	-
Sequence 6	Treatment B	-
Sequence 3	Treatment B	-
Sequence 3	Treatment C	-
Sequence 3	Treatment A	-
Sequence 4	Treatment B	-
Sequence 4	Treatment A	-
Sequence 4	Treatment C	-
Sequence 5	Treatment C	-
Sequence 5	Treatment A	-
Sequence 5	Treatment B	-
Sequence 6	Treatment C	-
Sequence 6	Treatment A	-

Primary Outcome Measures

Name	Time	Method
PK parameters: AUCinf, AUClast and Cmax of tasocitinib (CP-690,550).	PK blood samples out to 24 hours post dose in each period

Secondary Outcome Measures

Name	Time	Method
PK parameters: Tmax, t½ of tasocitinib (CP-690,550).	Derived from PK blood samples out to 24 hours post dose in each period.
Safety: laboratory tests.	Pre-dose on Day 0 for Period 1 and at 24 hours post last dose in Period 3.
Safety: vital signs	Prior to dosing in each period and at 24 hours post last dose in Period 3.
Safety: adverse event reporting	Throughout study.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇬 Singapore, Singapore