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Single Dose Study of PF-05230907 in Healthy Japanese Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02537002
Recruitment Status : Completed
First Posted : September 1, 2015
Last Update Posted : April 29, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE August 28, 2015
First Posted Date  ICMJE September 1, 2015
Last Update Posted Date April 29, 2016
Study Start Date  ICMJE September 2015
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2015)
Incidence of Adverse Events and Serious Adverse Events Per Participant of PF-05230907 [ Time Frame: up to 2 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2015)
  • Single dose Time to Reach maximum Observed Plasma Concentration (Tmax) of PF-05230907 [ Time Frame: Minute 0, 2, 5, 15, 40, 60 minute post-dose ]
  • Single dose Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]of PF-05230907 [ Time Frame: Minute 0, 2, 5, 15, 40, 60 minute post-dose ]
  • Single dose Plasma Decay Half-Life (t1/2) of PF-05230907 [ Time Frame: Minute 0, 2, 5, 15, 40, 60 minute post-dose ]
  • Single dose steady state Volume of Distribution (Vss) of PF-05230907 [ Time Frame: Minute 0, 2, 5, 15, 40, 60 minute post-dose ]
  • Single dose clearance (CL) of PF-05230907 [ Time Frame: Minute 0, 2, 5, 15, 40, 60 minute post-dose ]
  • Single dose Maximum Observed plasma concentration (Cmax) of PF-05230907 [ Time Frame: Minute 0, 2, 5, 15, 40, 60 minute post-dose ]
  • Single dose Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (last)]of PF-05230907 [ Time Frame: Minute 0, 2, 5, 15, 40, 60 minute post-dose ]
  • Change of aPTT from pre-dose to post-dose [ Time Frame: Hour 0, 24 hour post-dose ]
  • Change of prothrombin fragments 1+2 (PF1+2) [ Time Frame: Hour 0, 24 hour post-dose ]
  • Change of plasma D-dimer [ Time Frame: Hour 0, 48 hour post-dose ]
  • Incidence of development of anti-drug antibody (ADA) [ Time Frame: up to 2 months ]
  • Incidence of development of neutralizing antibody (NAb) [ Time Frame: up to 2 months ]
  • Change of factor X activity [ Time Frame: up to 2 months ]
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 Single Dose Study of PF-05230907 in Healthy Japanese Subjects
Official Title  ICMJE A Phase 1, Randomized, Double-blind, Sponsor-open, Placebo-controlled, Single Ascending Dose Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of An Intravenous Bolus Infusion Pf-05230907 In Healthy Japanese Subjects
Brief Summary

The purpose of this study is the following:

  • To determine the safety and tolerability of single ascending intravenous (IV) doses of PF-05230907 in healthy Japanese subjects.
  • To characterize the PK profile of single ascending IV doses of PF-05230907 in healthy Japanese subjects.
  • To characterize the PD profiles of single ascending IV doses of PF-05230907 in healthy Japanese subjects.
  • To evaluate the immunogenicity of PF-05230907 in healthy Japanese subjects
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: PF-05230907
    A single intravenous dose of 3 μg/kg
  • Drug: PF-05230907
    A single intravenous dose of 5 μg/kg
  • Drug: Placebo
    A single intravenous dose of matched placebo
Study Arms  ICMJE
  • Experimental: Cohort 1- PF-05230907 or Placebo
    Interventions:
    • Drug: PF-05230907
    • Drug: Placebo
  • Experimental: Cohort 2- PF-05230907 or Placebo
    Interventions:
    • Drug: PF-05230907
    • Drug: Placebo
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: April 20, 2016)
17
Original Estimated Enrollment  ICMJE
 (submitted: August 28, 2015)
12
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male of females
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs) and <120 kg (265 lbs).
  • Japanese subjects who have four biologic Japanese grandparents born in Japan.

Exclusion Criteria:

  • Pregnant or nursing females.
  • Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception.
  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 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 NCT02537002
Other Study ID Numbers  ICMJE B2341003
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 April 2016

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