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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Clinical Research Unit
Brussels, , B-1070 Belgium
Contact
1-800-718-1021
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.

NCT01897142
Pfizer
Completed
A Phase 1 Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-05230907 In Healthy Volunteers

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A Phase 1 Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-05230907 In Healthy Volunteers
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Healthy
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
March 2015
March 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 35 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01897142
B2341001
2013-001387-36 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 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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