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A Pharmacokinetic Study of CVX-096 (PF-04856883) in Healthy Volunteers

This study has been completed.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: June 26, 2012
Last updated: July 30, 2015
Last verified: July 2015
The purpose of the study is to further evaluate the PK characteristics of PF-04856883.

Condition Intervention Phase
Biological: PF-04856883
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Phase 1, Randomized, Open-label, Parallel-group Study To Evaluate The Pharmacokinetics Of Pf-04856883 (Cvx-096) Following Subcutaneous Administration In Healthy Volunteers

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • PF-04856883 Pharmacokinetics including Cmax, Tmax, AUCo-infinity, AUClast, Cl/F, Vz/F and t1/2 [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of subjects with AEs reported [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with abnormal physical examination findings [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with abnormal clinical laboratory results [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with abnormal ECGs [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with abnormal vital signs [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 49
Study Start Date: August 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-04856883 Treatment Arm 1 Biological: PF-04856883
Dose A
Experimental: PF-04856883 Treatment Arm 2 Biological: PF-04856883
Dose B
Experimental: PF-04856883 Treatment Arm 3 Biological: PF-04856883
Dose C
Experimental: PF-04856883 Treatment Arm 4 Biological: PF-04856883
Dose D


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

Inclusion Criteria:

Exclusion Criteria:

  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 identifier: NCT01637285

United States, Connecticut
New Haven Clinical Research Unit
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Responsible Party: Pfizer Identifier: NCT01637285     History of Changes
Other Study ID Numbers: B1111005 
Study First Received: June 26, 2012
Last Updated: July 30, 2015
Health Authority: United States: Food and Drug Administration processed this record on December 07, 2016