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

NCT01184001 | Completed Phase 1

• 1 other identifier: A3921076
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatoid Arthritis

Keywords

Healthy subjects; Food Effect Study

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (4)

• AUClast, Tmax, and t1/2 of tasocitinib (CP-690,550).

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

• Safety: Laboratory tests.

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

• Safety:Vital signs.

  Prior to dosing in Period 1 and 2.

• Safety: AE reporting.

  Continuous

Study Arms (2)

Sequence 1

EXPERIMENTAL

Drug: Treatment A; Drug: Treatment B

Sequence 2

EXPERIMENTAL

Drug: Treatment B; Drug: Treatment A

Interventions

Treatment A DRUG

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

Sequence 1

Treatment B DRUG

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

Sequence 1

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Singapore, 188770, Singapore

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 17, 2010
• First Posted: August 18, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: October 13, 2010

Record last verified: 2010-10

Locations

SG (1)