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

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: May 11, 2010
Last updated: November 19, 2010
Last verified: November 2010

This study will evaluate the safety, tolerability, and pharmacokinetics of PF-04236921 administered as a single subcutaneous dose in healthy volunteers.

Condition Intervention Phase
Drug: PF-04236921
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Phase I Pharmacokinetics And Tolerability Of PF-04236921 Following Subcutaneous Administration To Healthy Volunteers

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Incidence and severity of adverse events [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
  • Incidence and severity of clinical findings on physical examination [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
  • Mean change from baseline in vital signs (blood pressure, pulse rate, oral or tympanic temperature) measurements [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Serum PF-04236921 concentrations will be determined by a validated assay and noncompartmental PK parameters [ Time Frame: 5 months ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]
  • Incidence and level of ADA development [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]

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


Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01166555

Pfizer Investigational Site
Bruxelles, Belgium, 1070
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. 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
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Safety and tolerability
Rheumatoid Arthritis processed this record on October 08, 2015