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Pharmacokinetics And Tolerability Of Subcutaneous Administration Of PF 04236921 In Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01166555
First received: May 11, 2010
Last updated: November 19, 2010
Last verified: November 2010
  Purpose
This study will evaluate the safety, tolerability, and pharmacokinetics of PF-04236921 administered as a single subcutaneous dose in healthy volunteers.

Condition Intervention Phase
Healthy Drug: PF-04236921 Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Incidence and severity of adverse events [ Time Frame: 5 months ]
  • Incidence and severity of clinical findings on physical examination [ Time Frame: 5 months ]
  • Mean change from baseline in vital signs (blood pressure, pulse rate, oral or tympanic temperature) measurements [ Time Frame: 5 months ]
  • 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 ]
  • Serum PF-04236921 concentrations will be determined by a validated assay and noncompartmental PK parameters [ Time Frame: 5 months ]

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

Enrollment: 10
Study Start Date: May 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: PF-04236921
single subcutaneous dose

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

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01166555

Locations
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, 1070
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01166555     History of Changes
Other Study ID Numbers: B0151004
EudraCT 2010-019770-32
Study First Received: May 11, 2010
Last Updated: November 19, 2010

Keywords provided by Pfizer:
Safety and tolerability
Pharmacokinetics
PF-04236921
Rheumatoid Arthritis

ClinicalTrials.gov processed this record on September 20, 2017