A Study To Compare The Amount Of Tasocitinib (CP-690,550) That Is Absorbed Into The Blood Of Healthy Subjects Following Oral Administration Of Three Different Tablet Versions Of Tasocitinib (CP-690,550)

NCT01184092 | Completed Phase 1

• 1 other identifier: A3921075
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, a 10 mg dose of tasocitinib (CP-690,550) will be given to study subjects on three separate occasions using one of three different tablet formulations (tablet versions) each time. The amount of tasocitinib (CP-690,550) available in the blood following administration of each tablet formulation will be measured and compared. The overall aim of the study is to establish that a similar amount of tasocitinib (CP-690,550) is absorbed into the blood following administration of the same dose of each different tablet formulation.

Conditions

Rheumatoid Arthritis

Keywords

Bioequivalence; healthy volunteer study; Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• PK parameters: AUCinf, AUClast and Cmax of tasocitinib (CP-690,550).

  PK blood samples out to 24 hours post dose in each period

Secondary Outcomes (4)

• PK parameters: Tmax, t½ of tasocitinib (CP-690,550).

  Derived from PK blood samples out to 24 hours post dose in each period.

• Safety: laboratory tests.

  Pre-dose on Day 0 for Period 1 and at 24 hours post last dose in Period 3.

• Safety: vital signs

  Prior to dosing in each period and at 24 hours post last dose in Period 3.

• Safety: adverse event reporting

  Throughout study.

Study Arms (6)

Sequence 1

EXPERIMENTAL

Drug: Treatment A; Drug: Treatment B; Drug: Treatment C

Sequence 2

EXPERIMENTAL

Drug: Treatment A; Drug: Treatment C; Drug: Treatment B

Sequence 3

EXPERIMENTAL

Drug: Treatment B; Drug: Treatment C; Drug: Treatment A

Sequence 4

EXPERIMENTAL

Drug: Treatment B; Drug: Treatment A; Drug: Treatment C

Sequence 5

EXPERIMENTAL

Drug: Treatment C; Drug: Treatment A; Drug: Treatment B

Sequence 6

EXPERIMENTAL

Drug: Treatment C; Drug: Treatment B; Drug: Treatment A

Interventions

Treatment A DRUG

Single oral dose of 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet).

Sequence 1

Treatment B DRUG

Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets).

Sequence 1

Treatment C DRUG

Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets).

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, inclusive.
• 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 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 16, 2010
• First Posted: August 18, 2010
• Study Start: August 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: October 14, 2010

Record last verified: 2010-10

Locations

SG (1)