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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01185184
Recruitment Status : Completed
First Posted : August 19, 2010
Last Update Posted : September 14, 2010
Information provided by:

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: CP-690,550 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Study Start Date : August 2010
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Arm Intervention/treatment
Experimental: 1
Subjects will receive in random order, the immediate release tablet containing 10 mg of CP-690,550 and two different controlled-release capsules containing 20 mg of CP-690,550.
Drug: CP-690,550
Single doses separated by a minimum of 72 hour washout between treatments

Primary Outcome Measures :
  1. Pharmacokinetic parameters: AUCinf(dn), Frel and Cmax(dn) of CP-690,550 [ Time Frame: 36 hours ]

Secondary Outcome Measures :
  1. Pharmacokinetic parameters: AUCinf, AUClast, AUClast(dn), Cmax, Tmax, t½, C12h, C24h of CP-690,550 [ Time Frame: 9 days ]
  2. Safety: laboratory tests, adverse events reporting, ECG and vital signs [ Time Frame: 9 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Months to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01185184

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Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer

Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT01185184     History of Changes
Other Study ID Numbers: A3921113
First Posted: August 19, 2010    Key Record Dates
Last Update Posted: September 14, 2010
Last Verified: September 2010
Keywords provided by Pfizer:
Relative bioavailability
controlled release
Phase 1
Additional relevant MeSH terms:
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Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action