Skip to main content
OpenTrials
Completed

NCT Number: NCT01184001

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Singapore, 188770

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Treatment A

Drug

Single dose of tasocitinib (CP-690,550) 10 mg under fed conditions.

Treatment B

Drug

Single dose of tasocitinib (CP-690,550) 10 mg under fasted conditions.

Primary outcomes

  1. AUCinf and Cmax of tasocitinib (CP-690,550).

    Time frame: PK blood samples out to 24 hours post dose in each of two periods.

Secondary outcomes

  1. 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.

  2. Safety: Laboratory tests.

    Time frame: Pre-dose on Day O of Period 1 and post-dose on Day 2 of Period 2.

  3. Safety:Vital signs.

    Time frame: Prior to dosing in Period 1 and 2.

  4. Safety: AE reporting.

    Time frame: Continuous

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Aug 18, 2010
Registry last updated
Oct 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.