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
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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:
No publications provided

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
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 28, 2014