A Phase 1 Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-05230907 In Healthy Volunteers

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NCT01897142

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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
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-35 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male subjects.

- Healthy non-child bearing female subjects.

- 18 to 35 years of age.

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


- Heart disease.


- Clotting disorders.


- Use of nicotine products.


- Diabetes.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Phase 1 Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-05230907 In Healthy Volunteers
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 Pf-05230907 In Healthy Subjects
Brief Summary The purpose of this study is to determine what the study drug does to the body, what the body does to the study drug, and if the study drug is safe and well tolerated when given to adult healthy volunteers.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Biological: PF-05230907
    0.1 micrograms per kilogram of PF-05230907, IV bolus, single dose
  • Drug: Placebo for PF-05230907
    0.1 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
  • Biological: PF-05230907
    0.3 micrograms per kilogram of PF-05230907, IV bolus, single dose
  • Drug: Placebo for PF-05230907
    0.3 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
  • Biological: PF-05230907
    1 micrograms per kilogram of PF-05230907, IV bolus, single dose
  • Drug: Placebo for PF-05230907
    1 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
  • Biological: PF-05230907
    2 micrograms per kilogram of PF-05230907, IV bolus, single dose
  • Drug: Placebo for PF-05230907
    2 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
  • Biological: PF-05230907
    3 micrograms per kilogram of PF-05230907, IV bolus, single dose
  • Drug: Placebo for PF-05230907
    3 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
  • Biological: PF-05230907
    5 micrograms per kilogram of PF-05230907, IV bolus, single dose
  • Drug: Placebo for PF-05230907
    5 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
Study Arms  ICMJE
  • Experimental: PF-05230907 and Placebo Cohort 1
    Interventions:
    • Biological: PF-05230907
    • Drug: Placebo for PF-05230907
  • Experimental: PF-05230907 and Placebo Cohort 2
    Interventions:
    • Biological: PF-05230907
    • Drug: Placebo for PF-05230907
  • Experimental: PF-05230907 and Placebo Cohort 3
    Interventions:
    • Biological: PF-05230907
    • Drug: Placebo for PF-05230907
  • Experimental: PF-05230907 and Placebo Cohort 4
    Interventions:
    • Biological: PF-05230907
    • Drug: Placebo for PF-05230907
  • Experimental: PF-05230907 and Placebo Cohort 5
    Interventions:
    • Biological: PF-05230907
    • Drug: Placebo for PF-05230907
  • Experimental: PF-05230907 and Placebo Cohort 6
    Interventions:
    • Biological: PF-05230907
    • Drug: Placebo for PF-05230907
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: May 1, 2015)		49
Original Estimated Enrollment  ICMJE
 (submitted: July 8, 2013)		48
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male subjects.
  • Healthy non-child bearing female subjects.
  • 18 to 35 years of age.

Exclusion Criteria:

  • Heart disease.
  • Clotting disorders.
  • Use of nicotine products.
  • Diabetes.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 35 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 NCT01897142
Other Study ID Numbers  ICMJE B2341001
2013-001387-36 ( EudraCT Number )
Has Data Monitoring Committee Yes
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 April 2016

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