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

June 26, 2012
January 17, 2013
August 2012
January 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01637285 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Pharmacokinetic Study of CVX-096 (PF-04856883) in Healthy Volunteers
A Phase 1, Randomized, Open-label, Parallel-group Study to Evaluate the Pharmacokinetics of CVX-096 (PF-04856883) Following Subcutaneous Administration in Healthy Volunteers

The purpose of the study is to further evaluate the PK characteristics of PF-04856883.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy
  • Biological: PF-04856883
    Dose A
  • Biological: PF-04856883
    Dose B
  • Biological: PF-04856883
    Dose C
  • Biological: PF-04856883
    Dose D
  • Experimental: PF-04856883 Treatment Arm 1
    Intervention: Biological: PF-04856883
  • Experimental: PF-04856883 Treatment Arm 2
    Intervention: Biological: PF-04856883
  • Experimental: PF-04856883 Treatment Arm 3
    Intervention: Biological: PF-04856883
  • Experimental: PF-04856883 Treatment Arm 4
    Intervention: Biological: PF-04856883
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
January 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01637285
B1111005
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP