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: January 17, 2013
Last verified: January 2013
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Phase 1, Randomized, Open-label, Parallel-group Study to Evaluate the Pharmacokinetics of CVX-096 (PF-04856883) 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: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male subjects and female of non-childbearing potential subjects between the ages of 18 and 55
  • BMI between 18.5 to 30.5 kg/m2

Exclusion Criteria:

  • Personal or family history of medullary thyroid cancer or a genetic disorder that predisposes to MTC
  • Pregnant or nursing females; females of childbearing potential
  • History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody or molecules made of components of monoclonal antibodies
  • History of clinically significant gastrointestinal disorder, including any disorder that may predispose to study drug intolerance
  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
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01637285     History of Changes
Other Study ID Numbers: B1111005
Study First Received: June 26, 2012
Last Updated: January 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Phase 1
CVX-096
Healthy Volunteers

ClinicalTrials.gov processed this record on July 28, 2014