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

A Phase 1, Randomized, 2-Period, 2-Sequence, Open Label, Single Dose, Cross-Over Study To Evaluate The Effect Of Food On Pharmacokinetics Of Tasocitinib (CP-690,550) Tablets In Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01184001

Enrollment

Registered

2010-08-18

Start date

2010-09-30

Completion date

2010-09-30

Last updated

2010-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Healthy subjects, Food Effect Study

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).

Interventions

DRUGTreatment A

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

DRUGTreatment B

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026