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
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 April 16, 2014