Multiple Dose Healthy Volunteer Study of PF-03715455.


Last updated date
Study Location
Pfizer Investigational Site
Singapore, , 188770, Singapore


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Eligibility Criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
Females and Males
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Healthy volunteers

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Standard healthy volunteer criteria


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Advanced Information
Descriptive Information
Brief Title  ICMJE Multiple Dose Healthy Volunteer Study of PF-03715455.
Official Title  ICMJE A Double Blind (3rd Party Open), Randomized, Placebo Controlled, Dose Escalation Study To Investigate The Safety, Toleration, And Pharmacokinetics Of Multiple Inhaled Doses Of PF-03715455 In Healthy Subjects
Brief Summary Evaluation of the multiple dose pharmacokinetics of PF-3715455 in healthy volunteers
Detailed Description Healthy volunteer PK study
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: PF-03715455
    PF-03715455 1.6 mg BID
  • Drug: PF-03715455
    PF-03715455 4mg BID
  • Drug: PF-03715455
    PF-03715455 10 mg BID
  • Drug: Placebo
Study Arms  ICMJE
  • Active Comparator: PF-03715455 1.6mg BID
    Intervention: Drug: PF-03715455
  • Active Comparator: PF-03715455 4 mg BID
    Intervention: Drug: PF-03715455
  • Active Comparator: PF-03715455 10 mg BID
    Intervention: Drug: PF-03715455
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 20, 2010)
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy volunteers

Exclusion Criteria:

  • Standard healthy volunteer criteria
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 21 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 Singapore
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01186757
Other Study ID Numbers  ICMJE A9111002
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 Call CenterPfizer
PRS Account Pfizer
Verification Date January 2011

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