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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.

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Bruxelles, , B-1070 Belgium
Contact
1-800-718-1021
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.

NCT01415102
Pfizer
Completed
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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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.
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
  • Phase 1
  • Single Dose
  • Safety
  • Toleration
  • Pharmacokinetics
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
December 2010
December 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01415102
B2031001
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2011

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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