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NCT01499004 Clinical Trial

A Phase 1 Study To Evaluate The Pharmacokinetics And Safety Of Three Modified Release And One Immediate Release Formulations Of Tofacitinib (CP-690,550) In Healthy Volunteers

Healthy Clinical Trial

Official title:
A Phase 1, Randomized, Open Label, Partial Crossover Study To Evaluate The Pharmacokinetics (PK) And Safety Of Three Modified Release (MR) And One Immediate Release (IR) Formulations Of Tofacitinib (CP-690,550) In Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01499004
Other study ID # A3921131
Secondary ID
Status Completed
Phase Phase 1
First received November 23, 2011
Last updated January 11, 2012
Start date November 2011
Est. completion date December 2011

Study information
Verified date January 2012
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Singapore: Health Sciences Authority
Study type Interventional

Clinical Trial Summary

This study will explore the drug behavior and safety following a single dose of three different 22 milligram tofacitinib (CP-690,550) modified-release formulations in 30 healthy volunteers. These formulations will be compared to 10 milligram tofacitinib (CP-690-550) in an immediate-release formulation.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years to 55 Years
Eligibility Inclusion Criteria:

- Healthy male subjects and/or healthy females subjects who are of non-childbearing potential.

Exclusion Criteria:

- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease;

- Clinically significant infections within the past 3 months

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• tofacitinib (CP-690,550) modified-release formulation A
A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation A administered with food.
• tofacitinib (CP-690,550) modified-release formulation B1
A single dose of 22 mg tofacitinib (CP-690,550) MR-B1 formulation administered with food
• tofacitinib (CP-690,550) modified-release formulation A
A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation A administered without food
• tofacitinib (CP-690,550) modified-release formulation B1
A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation B1 administered without food
• tofacitinib (CP-690,550) modified-release formulation B2
A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation B2 administered without food
• tofacitinib (CP-690,550) immediate-release formulation
A single dose of 10 mg tofacitinib (CP-690,550) immediate-release formulation administered without food

Locations
Country Name City State
Singapore Pfizer Investigational Site Singapore

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Singapore, 

Outcome
Type Measure Description Time frame Safety issue
Primary AUCinf: Area under the plasma concentration-time profile from time 0 exprapolated to infinite time 72 hours post dose No
Primary AUClast: Area under the plasma concentration-time profile from time 0 to the last with quantifiable concentration 72 hours post dose No
Primary Cmax: Maximum plasma concentration of tofacitinib (CP-690,550) 72 hours post dose No
Primary Tmax: Amount of time tofacitinib (CP-690,550) is at maximum plasma concentration 72 hours post dose No
Primary t1/2: The time required for one half of the total amount of tofacitinib (CP-690,550) to be removed from the plasma 72 hours post dose No
Secondary Frel: Relative bioavailability (Frel) of tofacitinib (CP-690,550) in the modified-release formulations compared to the immediate release formulation 24 hours post dose No
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