A Study To Evaluate The Effect Of Food On How Tasocitinib (CP-690,550) Is Absorbed And Moves Through The Body Following Oral Administration Of Tasocitinib (CP-690,550) Tablets To Healthy Subjects

Phase 1

Completed

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

• Registration Number: NCT01184001
• Lead Sponsor: Pfizer

Brief Summary

In this study, a 10 mg tasocitinib (CP-690,550) tablet will be administered to healthy subjects on two separate dosing occasions. On one occasion the tasocitinib (CP-690,550) tablet will be administered in a fasting condition; On the other occasion the tasocitinib (CP-690,550) tablet will be administered in a fed condition following a standard breakfast meal. The amount of tasocitinib (CP-690,550) in the blood will be measured at various times over 24 hours following each dosing occasion and compared to evaluate for any differences.

Detailed Description

To evaluate the effect of food on the pharmacokinetics of tasocitinib (CP-690,550).

Study Timeline

• Study First Submitted: 2010-08-17
• Study First Submitted QC: 2010-08-17
• Study First Posted: 2010-08-18
• Study Start: 2010-09
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-12
• Last Update Posted: 2010-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Healthy male and/or female (non-childbearing potential) subjects between the ages of 21 and 55 years.
• 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 or history 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 2	Treatment B	-
Sequence 2	Treatment A	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
AUClast, Tmax, and t1/2 of tasocitinib (CP-690,550).	PK blood samples out to 24 hours post dose in each of two periods.
Safety: Laboratory tests.	Pre-dose on Day O of Period 1 and post-dose on Day 2 of Period 2.
Safety:Vital signs.	Prior to dosing in Period 1 and 2.
Safety: AE reporting.	Continuous

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇬 Singapore, Singapore