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NCT01185184 Clinical Trial

Pharmacokinetics And Safety Study Of Two CP-690,550 Controlled Release Formulation Following Single Dose In Healthy Volunteers

Healthy Clinical Trial

Official title:
A Phase 1, Randomized, 3-Period, Open Label, Single Dose, Cross Over Study To Evaluate The Pharmacokinetics And Safety Of Two Controlled Release Formulations Of CP-690,550

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01185184
Other study ID # A3921113
Secondary ID
Status Completed
Phase Phase 1
First received August 18, 2010
Last updated September 13, 2010
Start date August 2010
Est. completion date August 2010

Study information
Verified date September 2010
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 single dose of two 20 milligram CP-690,550 osmotic capsules in 12 healthy volunteers. These will be compared to a 10 milligram immediate release tablet, using a 3 way crossover design.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date August 2010
Est. primary completion date August 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Months to 55 Years
Eligibility Inclusion Criteria:

- Healthy male and/or female subjects

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:
• CP-690,550
Single doses separated by a minimum of 72 hour washout between treatments

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 Pharmacokinetic parameters: AUCinf(dn), Frel and Cmax(dn) of CP-690,550 36 hours No
Secondary Pharmacokinetic parameters: AUCinf, AUClast, AUClast(dn), Cmax, Tmax, t½, C12h, C24h of CP-690,550 9 days No
Secondary Safety: laboratory tests, adverse events reporting, ECG and vital signs 9 days Yes
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