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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01637285
First received: June 26, 2012
Last updated: July 30, 2015
Last verified: July 2015
  Purpose
The purpose of the study is to further evaluate the PK characteristics of PF-04856883.

Condition Intervention Phase
Healthy
Biological: PF-04856883
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
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 ]

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

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

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01637285

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

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01637285     History of Changes
Other Study ID Numbers: B1111005 
Study First Received: June 26, 2012
Last Updated: July 30, 2015

ClinicalTrials.gov processed this record on January 19, 2017