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Trial record 1 of 1 for:    NCT01186757
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Multiple Dose Healthy Volunteer Study of PF-03715455. (MD-MULTI DOSE)

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ClinicalTrials.gov Identifier: NCT01186757
Recruitment Status : Completed
First Posted : August 23, 2010
Last Update Posted : January 12, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE August 11, 2010
First Posted Date  ICMJE August 23, 2010
Last Update Posted Date January 12, 2011
Study Start Date  ICMJE August 2010
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2010)
Pharmacokinetics of single and multiple inhaled doses of PF-03715455, as measured by plasma concentrations - Cmax, Tmax, AUCtau, t½, accumulation ratio (Rac, Rss, Rac,Cmax). [ Time Frame: 17 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 20, 2010)
Pharmacokinetics of single and multiple inhaled doses of PF-03715455, as measured by plasma concentrations - Cmax, Tmax, AUCinf, AUC, t½, accumulation ratio (Rac, Rss, Rac,Cmax). [ Time Frame: 14 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2010)
Safety and toleration as measured by adverse events, vital signs, 12 lead ECG, blood and urine safety tests and physical examination. [ Time Frame: 28 Days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2010)
Safety and toleration as measured by adverse events, vital signs, 12 lead ECG, blood and urine safety tests and physical examination. [ Time Frame: 14 Days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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
    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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 20, 2010)
36
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 CT.gov Call Center Pfizer
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