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Dose Escalation Study of PF-06741086 In Healthy Subjects

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NCT02531815

Last updated on March 22, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Clinical Research Unit
Brussels, , B-1070 Belgium
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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

NCT02531815
Pfizer
Completed
Dose Escalation Study of PF-06741086 In Healthy Subjects

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Dose Escalation Study of PF-06741086 In Healthy Subjects
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Healthy
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
July 2016
July 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT02531815
B7841001
2015-001821-17 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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