Dose Escalation Study of PF-06741086 In Healthy Subjects

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NCT02531815

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Study Location
Pfizer Clinical Research Unit
Brussels, , B-1070, Belgium
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs) and 100 kg (220 lbs).

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Increased risk of thrombosis (coronary artery disease, hypercholesterolemia, diabetes)


- Use of nicotine/tobacco products


- Clotting disorders

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Advanced Information
Descriptive Information
Brief Title  ICMJE Dose Escalation Study of PF-06741086 In Healthy Subjects
Official Title  ICMJE A Randomized, Double-blind, Sponsor-open, Placebo-controlled, Single Intravenous Or Subcutaneous Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Pf-06741086 In Healthy Subjects And An Open-label Evaluation In Healthy Japanese Subjects
Brief Summary This Phase 1 first-in-human single ascending dose study will be a randomized, double-blind, placebo-controlled investigation of the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06741086.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Biological: PF-06741086
    PF-06741086, single dose, beginning with Cohort 1 dose level at 30 mg. Subsequent dose levels will be determined after data review of prior cohort(s)
  • Drug: Placebo
    Placebo for PF-06741086, single dose
    Other Name: saline placebo
Study Arms  ICMJE
  • Experimental: Cohort 1 (subcutaneous [SC]) PF-06741086, Placebo
    Interventions:
    • Biological: PF-06741086
    • Drug: Placebo
  • Experimental: Cohort 2 (SC) PF-06741086, Placebo
    Interventions:
    • Biological: PF-06741086
    • Drug: Placebo
  • Experimental: Cohort 3 (SC) PF-06741086, Placebo
    Interventions:
    • Biological: PF-06741086
    • Drug: Placebo
  • Experimental: Cohort 4 (Intravenous [IV]) PF-06741086, Placebo
    Interventions:
    • Biological: PF-06741086
    • Drug: Placebo
  • Experimental: Cohort 5 (IV) PF-06741086, Placebo
    Interventions:
    • Biological: PF-06741086
    • Drug: Placebo
  • Experimental: Cohort 6 (IV) PF-06741086, Placebo
    Interventions:
    • Biological: PF-06741086
    • Drug: Placebo
  • Experimental: Cohort 7 (IV) PF-06741086, Placebo
    Interventions:
    • Biological: PF-06741086
    • Drug: Placebo
  • Experimental: Cohort 8 (subcutaneous [SC]) PF-06741086
    Intervention: Biological: PF-06741086
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: August 10, 2016)		41
Original Estimated Enrollment  ICMJE
 (submitted: August 20, 2015)		52
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs) and 100 kg (220 lbs).

Exclusion Criteria:

  • Increased risk of thrombosis (coronary artery disease, hypercholesterolemia, diabetes)
  • Use of nicotine/tobacco products
  • Clotting disorders
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
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 Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02531815
Other Study ID Numbers  ICMJE B7841001
2015-001821-17 ( EudraCT Number )
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 CenterPfizer
PRS Account Pfizer
Verification Date August 2016

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