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, Open-Label, Randomized, Single-Dose, 3-Treatment, 3-Period, Cross-Over, Bioequivalence Study Comparing Phase 2b, Phase 3 And Commercial Image Tablet Formulations Of Tasocitinib (CP-690,550) Under Fasted Conditions

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01184092

Enrollment

Registered

2010-08-18

Start date

2010-08-31

Completion date

2010-09-30

Last updated

2010-10-14

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

Conditions

Rheumatoid Arthritis

Keywords

Bioequivalence, healthy volunteer study, Rheumatoid Arthritis

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).

Interventions

DRUGTreatment A

Single oral dose of 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet).

DRUGTreatment B

Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets).

DRUGTreatment C

Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets).

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, 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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.

Countries

Singapore

Outcome results

None listed

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