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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01184001
• Other study ID #: A3921076
• Status: Completed
• Phase: Phase 1
• First received: August 17, 2010
• Last updated: October 12, 2010
• Start date: September 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 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• 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.

• 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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Treatment A
Single dose of tasocitinib (CP-690,550) 10 mg under fed conditions.
• Treatment B
Single dose of tasocitinib (CP-690,550) 10 mg under fasted conditions.
• Treatment B
Single dose of tasocitinib (CP-690,550) 10 mg under fasted conditions.
• Treatment A
Single dose of tasocitinib (CP-690,550) 10 mg under fed conditions.

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	AUCinf and Cmax of tasocitinib (CP-690,550).		PK blood samples out to 24 hours post dose in each of two periods.	No
Secondary	AUClast, Tmax, and t1/2 of tasocitinib (CP-690,550).		PK blood samples out to 24 hours post dose in each of two periods.	No
Secondary	Safety: Laboratory tests.		Pre-dose on Day O of Period 1 and post-dose on Day 2 of Period 2.	Yes
Secondary	Safety:Vital signs.		Prior to dosing in Period 1 and 2.	Yes
Secondary	Safety: AE reporting.		Continuous	Yes

External Links

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