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Pharmacokinetics And Tolerability Of Subcutaneous Administration Of PF 04236921 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: NCT01166555
Recruitment Status : Completed
First Posted : July 21, 2010
Last Update Posted : November 23, 2010
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Brief Summary:
This study will evaluate the safety, tolerability, and pharmacokinetics of PF-04236921 administered as a single subcutaneous dose in healthy volunteers.

Condition or disease Intervention/treatment Phase
Healthy Drug: PF-04236921 Phase 1

Detailed Description:
Tolerability and Pharmacokinetics of subcutaneously administered dose of PF-04236921 in healthy volunteers

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Phase I Pharmacokinetics And Tolerability Of PF-04236921 Following Subcutaneous Administration To Healthy Volunteers
Study Start Date : May 2010
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Arm Intervention/treatment
Experimental: 1 Drug: PF-04236921
single subcutaneous dose

Primary Outcome Measures :
  1. Incidence and severity of adverse events [ Time Frame: 5 months ]
  2. Incidence and severity of clinical findings on physical examination [ Time Frame: 5 months ]
  3. Mean change from baseline in vital signs (blood pressure, pulse rate, oral or tympanic temperature) measurements [ Time Frame: 5 months ]
  4. Mean change from baseline in 12-lead electrocardiogram (ECG) parameters: PRI, RR, QRS, QT, QTcF (Freidericia's correction) and HR (heart rate) [ Time Frame: 5 months ]
  5. Serum PF-04236921 concentrations will be determined by a validated assay and noncompartmental PK parameters [ Time Frame: 5 months ]

Secondary Outcome Measures :
  1. Incidence and severity of clinical laboratory abnormalities including absolute neturophil count, hepatic transaminases and bilirubin levels, and lipid profiles [ Time Frame: 5 months ]
  2. Incidence and level of ADA development [ Time Frame: 5 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy males between 18-55 years, inclusive.
  • Healthy females of non-childbearing potential between 18 and 55 years, inclusive.

Exclusion Criteria:

  • Evidence or history of clinically significant disease.
  • Females of childbearing potential.

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): NCT01166555

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Pfizer Investigational Site
Bruxelles, Belgium, 1070
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT01166555    
Other Study ID Numbers: B0151004
EudraCT 2010-019770-32
First Posted: July 21, 2010    Key Record Dates
Last Update Posted: November 23, 2010
Last Verified: November 2010
Keywords provided by Pfizer:
Safety and tolerability
Rheumatoid Arthritis