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
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 April 15, 2014