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Trial record 1 of 1 for:    NCT01226693
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A Study In Healthy Volunteers To Assess The Safety, Tolerability, And Relative Oral Bioavailability Of Three Formulations Of PH-797804

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01226693
Recruitment Status : Completed
First Posted : October 22, 2010
Last Update Posted : March 10, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE October 20, 2010
First Posted Date  ICMJE October 22, 2010
Last Update Posted Date March 10, 2011
Study Start Date  ICMJE November 2010
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2010)
  • Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf) [ Time Frame: predose to day 7 of treatment period ]
  • Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast) [ Time Frame: predose to day 7 of treatment period ]
  • Maximum observed concentration within the dosing interval (Cmax) [ Time Frame: predose to day 7 of treatment period ]
  • Time for Cmax (Tmax) [ Time Frame: predose to day 7 of treatment period ]
  • Terminal half-life (t1/2) [ Time Frame: predose to day 7 of treatment period ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study In Healthy Volunteers To Assess The Safety, Tolerability, And Relative Oral Bioavailability Of Three Formulations Of PH-797804
Official Title  ICMJE A Phase 1, Randomized, Open Label, Single Dose, 3 Treatment, Two Period, Balanced Incomplete Block Study In Healthy Fasted Volunteers To Assess The Safety, Tolerability, And Relative Oral Bioavailability Of A 6 Mg Dose Of The PH-797804 Material Sparing Tablet (MST) And Two Modified Versions Of The MST Formulation With And Without The Solubilizing Agent Sodium Lauryl Sulphate (SLS)
Brief Summary There is no difference in the rate and extent of absorption of the material sparing tablet (MST), the Phase2b/3 formulation (P2b/3) with sodium lauryl sulphate (SLS) and the p2b/3 formulation without SLS.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: PH-797804 material sparing tablet
    oral, 6mg, single dose
  • Drug: PH-797804 Phase2b/3 with sodium lauryl sulphate
    oral, 6mg, single dose
  • Drug: PH-797804 Phase2b/3 without sodium lauryl sulphate
    oral, 6mg, single dose
Study Arms  ICMJE
  • Experimental: Sequence 1
    Interventions:
    • Drug: PH-797804 material sparing tablet
    • Drug: PH-797804 Phase2b/3 with sodium lauryl sulphate
  • Experimental: Sequence 2
    Interventions:
    • Drug: PH-797804 Phase2b/3 with sodium lauryl sulphate
    • Drug: PH-797804 material sparing tablet
  • Experimental: Sequence 3
    Interventions:
    • Drug: PH-797804 material sparing tablet
    • Drug: PH-797804 Phase2b/3 without sodium lauryl sulphate
  • Experimental: Sequence 4
    Interventions:
    • Drug: PH-797804 Phase2b/3 without sodium lauryl sulphate
    • Drug: PH-797804 material sparing tablet
  • Experimental: Sequence 5
    oral, 6mg, single dose
    Interventions:
    • Drug: PH-797804 Phase2b/3 without sodium lauryl sulphate
    • Drug: PH-797804 Phase2b/3 with sodium lauryl sulphate
  • Experimental: Sequence 6
    oral, 6mg, single dose
    Interventions:
    • Drug: PH-797804 Phase2b/3 with sodium lauryl sulphate
    • Drug: PH-797804 Phase2b/3 without sodium lauryl sulphate
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: October 20, 2010)
18
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and female subjects of non-childbearing potential between the ages of 21 and 55.
  • No evidence of active or latent TB.
  • An informed consent document signed and dated by the subject.

Exclusion Criteria:

  • Evidence, including abnormal clinical laboratory parameters, eg, liver enzyme elevations, or a 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).
  • Any condition possibly affecting drug absorption (eg, gastrectomy) or any active GI disease (including any relevant surgery).
  • Any current and clinically significant skin lesions as described in Common Terminology Criteria for Adverse Events for Dermatology (CTCAE) Version 3. A clinically significant skin lesion is defined as Grade 1 (mild) for rash and pruritus, and Grade 2 (moderate) or above for all other lesions (see Short Name description in CTCAE for specific description of lesion).
  • Use of prescription or nonprescription drugs, vitamins and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
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 NCT01226693
Other Study ID Numbers  ICMJE A6631028
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 March 2011

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