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)

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01184092
• Other study ID #: A3921075
• Status: Completed
• Phase: Phase 1
• First received: August 16, 2010
• Last updated: October 12, 2010
• Start date: August 2010
• Est. completion date: September 2010

Study information

• Verified date: October 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Treatment 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).
• Treatment B
Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets).
• Treatment C
Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets).
• Treatment 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).
• Treatment C
Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets).
• Treatment B
Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets).
• Treatment B
Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets).
• Treatment C
Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets).
• Treatment 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).
• Treatment B
Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets).
• Treatment 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).
• Treatment C
Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets).
• Treatment C
Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets).
• Treatment 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).
• Treatment B
Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets).
• Treatment C
Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets).
• Treatment B
Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets).
• Treatment 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).

Locations

Country	Name	City	State
Singapore	Pfizer Investigational Site	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK parameters: AUCinf, AUClast and Cmax of tasocitinib (CP-690,550).		PK blood samples out to 24 hours post dose in each period	No
Secondary	PK parameters: Tmax, t½ of tasocitinib (CP-690,550).		Derived from PK blood samples out to 24 hours post dose in each period.	No
Secondary	Safety: laboratory tests.		Pre-dose on Day 0 for Period 1 and at 24 hours post last dose in Period 3.	Yes
Secondary	Safety: vital signs		Prior to dosing in each period and at 24 hours post last dose in Period 3.	Yes
Secondary	Safety: adverse event reporting		Throughout study.	Yes

External Links

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