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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01184001
First received: August 17, 2010
Last updated: October 12, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: Treatment A
Drug: Treatment B
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • AUCinf and Cmax of tasocitinib (CP-690,550). [ Time Frame: PK blood samples out to 24 hours post dose in each of two periods. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUClast, Tmax, and t1/2 of tasocitinib (CP-690,550). [ Time Frame: PK blood samples out to 24 hours post dose in each of two periods. ] [ Designated as safety issue: No ]
  • Safety: Laboratory tests. [ Time Frame: Pre-dose on Day O of Period 1 and post-dose on Day 2 of Period 2. ] [ Designated as safety issue: Yes ]
  • Safety:Vital signs. [ Time Frame: Prior to dosing in Period 1 and 2. ] [ Designated as safety issue: Yes ]
  • Safety: AE reporting. [ Time Frame: Continuous ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: September 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sequence 1 Drug: Treatment A
Single dose of tasocitinib (CP-690,550) 10 mg under fed conditions.
Drug: Treatment B
Single dose of tasocitinib (CP-690,550) 10 mg under fasted conditions.
Experimental: Sequence 2 Drug: Treatment B
Single dose of tasocitinib (CP-690,550) 10 mg under fasted conditions.
Drug: Treatment A
Single dose of tasocitinib (CP-690,550) 10 mg under fed conditions.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01184001

Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01184001     History of Changes
Other Study ID Numbers: A3921076
Study First Received: August 17, 2010
Last Updated: October 12, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Healthy subjects
Food Effect Study

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 28, 2014