A First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Inhaled Doses Of PF-05212372.

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NCT01415102

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Study Location
Pfizer Investigational Site
Bruxelles, , B-1070, Belgium
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Contact
1-800-718-1021
[email protected]
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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Phase 1, Single Dose, Safety, Toleration, Pharmacokinetics
Sex
Females and Males
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

Healthy subjects. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).

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


- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing).


- A positive urine drug screen.


- Treatment with an investigational drug within the past 30 days (or local regulations)
or 5 half-lives preceding the first dose of study medication.

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Phase 1, Single Dose, Safety, Toleration, PharmacokineticsA First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Inhaled Doses Of PF-05212372.
NCT01415102
  1. Bruxelles,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Inhaled Doses Of PF-05212372.
Official Title  ICMJE A Double Blind (3rd Party Open), Randomised, Placebo-Controlled, Dose Escalation Study To Investigate The Safety, Toleration, And Pharmacokinetics Of Single Inhaled Doses Of Pf-05212372 In Healthy Subjects
Brief Summary The purpose of this study in healthy people is to evaluate safety, toleration and time course of plasma concentration of single inhaled doses of PF-05212372.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE
  • Phase 1
  • Single Dose
  • Safety
  • Toleration
  • Pharmacokinetics
Intervention  ICMJE
  • Drug: PF-05212372
    Inhaled. Dose Level 1: 50 ug
  • Drug: PF-05212372
    Inhaled. Dose Level 2 - Dose to be selected based upon safety/tolerability/PK at preceding dose
  • Drug: PF-05212372
    Inhaled. Dose Level 3 - Dose to be selected based upon safety/tolerability/PK at preceding dose
  • Drug: PF-05212372
    Inhaled. Dose Level 4 - Dose to be selected based upon safety/tolerability/PK at preceding dose
  • Drug: Placebo
    Inhaled
  • Drug: PF-05212372
    Inhaled. Dose Level 5 - Dose to be selected based upon safety/tolerability/PK at preceding dose
  • Drug: PF-05212372
    Inhaled. Dose Level 6 - Dose to be selected based upon safety/tolerability/PK at preceding dose
  • Drug: PF-05212372
    Inhaled. Dose Level 7 - Dose to be selected based upon safety/tolerability/PK at preceding dose
Study Arms  ICMJE
  • Experimental: Cohort 1
    Subjects will be assigned to receive either PF-05212372 or placebo in each period
    Interventions:
    • Drug: PF-05212372
    • Drug: PF-05212372
    • Drug: PF-05212372
    • Drug: PF-05212372
    • Drug: Placebo
  • Experimental: Cohort 2
    Subjects will be assigned to receive either PF-05212372 or placebo in each period
    Interventions:
    • Drug: PF-05212372
    • Drug: PF-05212372
    • Drug: PF-05212372
    • 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: August 10, 2011)		24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Healthy subjects. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • A positive urine drug screen.
  • Treatment with an investigational drug within the past 30 days (or local regulations) or 5 half-lives preceding the first dose of study medication.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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 NCT01415102
Other Study ID Numbers  ICMJE B2031001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2011

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