A Study In Healthy Volunteers To Assess The Safety, Tolerability, And Relative Oral Bioavailability Of Three Formulations Of PH-797804

Overview

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.

Full Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2011

Interventions

  • 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 with sodium lauryl sulphate
    • oral, 6mg, single dose
  • Drug: PH-797804 material sparing tablet
    • oral, 6mg, single dose
  • Drug: PH-797804 material sparing tablet
    • oral, 6mg, single dose
  • Drug: PH-797804 Phase2b/3 without sodium lauryl sulphate
    • oral, 6mg, single dose
  • Drug: PH-797804 Phase2b/3 without sodium lauryl sulphate
    • oral, 6mg, single dose
  • Drug: PH-797804 material sparing tablet
    • oral, 6mg, single dose
  • Drug: PH-797804 Phase2b/3 without sodium lauryl sulphate
    • oral, 6mg, single dose
  • Drug: PH-797804 Phase2b/3 with sodium lauryl sulphate
    • 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

Arms, Groups and Cohorts

  • Experimental: Sequence 1
  • Experimental: Sequence 2
  • Experimental: Sequence 3
  • Experimental: Sequence 4
  • Experimental: Sequence 5
    • oral, 6mg, single dose
  • Experimental: Sequence 6
    • oral, 6mg, single dose

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Pfizer
  • Provider of Information About this Clinical Study
    • Director, Clinical Trial Disclosure Group, Pfizer, Inc.
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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