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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01226693
First Posted: October 22, 2010
Last Update Posted: March 10, 2011
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.
Information provided by:
Pfizer
  Purpose
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.

Condition Intervention Phase
Healthy Drug: PH-797804 material sparing tablet Drug: PH-797804 Phase2b/3 with sodium lauryl sulphate Drug: PH-797804 Phase2b/3 without sodium lauryl sulphate Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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)

Further study details as provided by Pfizer:

Primary Outcome 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 ]

Enrollment: 18
Study Start Date: November 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sequence 1 Drug: PH-797804 material sparing tablet
oral, 6mg, single dose
Drug: PH-797804 Phase2b/3 with sodium lauryl sulphate
oral, 6mg, single dose
Experimental: Sequence 2 Drug: PH-797804 Phase2b/3 with sodium lauryl sulphate
oral, 6mg, single dose
Drug: PH-797804 material sparing tablet
oral, 6mg, single dose
Experimental: Sequence 3 Drug: PH-797804 material sparing tablet
oral, 6mg, single dose
Drug: PH-797804 Phase2b/3 without sodium lauryl sulphate
oral, 6mg, single dose
Experimental: Sequence 4 Drug: PH-797804 Phase2b/3 without sodium lauryl sulphate
oral, 6mg, single dose
Drug: PH-797804 material sparing tablet
oral, 6mg, single dose
Experimental: Sequence 5
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
Experimental: Sequence 6
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01226693


Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01226693     History of Changes
Other Study ID Numbers: A6631028
First Submitted: October 20, 2010
First Posted: October 22, 2010
Last Update Posted: March 10, 2011
Last Verified: March 2011

Keywords provided by Pfizer:
pharmacokinetic
single dose bioequivalence study
balanced incomplete block design
PH-797804
P38 kinase inhibitor