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

NCT ID: NCT01184001

Last Updated: 2010-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2010-09-30

Brief Summary

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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

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

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Sequence 1

Group Type EXPERIMENTAL

Treatment A

Intervention Type DRUG

Single dose of tasocitinib (CP-690,550) 10 mg under fed conditions.

Treatment B

Intervention Type DRUG

Single dose of tasocitinib (CP-690,550) 10 mg under fasted conditions.

Sequence 2

Group Type EXPERIMENTAL

Treatment B

Intervention Type DRUG

Single dose of tasocitinib (CP-690,550) 10 mg under fasted conditions.

Treatment A

Intervention Type DRUG

Single dose of tasocitinib (CP-690,550) 10 mg under fed conditions.

Interventions

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Treatment A

Single dose of tasocitinib (CP-690,550) 10 mg under fed conditions.

Intervention Type DRUG

Treatment B

Single dose of tasocitinib (CP-690,550) 10 mg under fasted conditions.

Intervention Type DRUG

Treatment B

Single dose of tasocitinib (CP-690,550) 10 mg under fasted conditions.

Intervention Type DRUG

Treatment A

Single dose of tasocitinib (CP-690,550) 10 mg under fed conditions.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Singapore, , Singapore

Site Status

Countries

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Singapore

Related Links

Other Identifiers

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A3921076

Identifier Type: -

Identifier Source: org_study_id