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Trial record 1 of 1 for:    NCT01637285
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A Pharmacokinetic Study of CVX-096 (PF-04856883) in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01637285
Recruitment Status : Completed
First Posted : July 11, 2012
Last Update Posted : July 31, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE June 26, 2012
First Posted Date  ICMJE July 11, 2012
Last Update Posted Date July 31, 2015
Study Start Date  ICMJE August 2012
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2012)
PF-04856883 Pharmacokinetics including Cmax, Tmax, AUCo-infinity, AUClast, Cl/F, Vz/F and t1/2 [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01637285 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pharmacokinetic Study of CVX-096 (PF-04856883) in Healthy Volunteers
Official Title  ICMJE A Phase 1, Randomized, Open-label, Parallel-group Study To Evaluate The Pharmacokinetics Of Pf-04856883 (Cvx-096) Following Subcutaneous Administration In Healthy Volunteers
Brief Summary The purpose of the study is to further evaluate the PK characteristics of PF-04856883.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy
Intervention  ICMJE
  • Biological: PF-04856883
    Dose A
  • Biological: PF-04856883
    Dose B
  • Biological: PF-04856883
    Dose C
  • Biological: PF-04856883
    Dose D
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 17, 2013)
49
Original Estimated Enrollment  ICMJE
 (submitted: July 6, 2012)
48
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

-

Exclusion Criteria:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01637285
Other Study ID Numbers  ICMJE B1111005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2015

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