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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:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01226693
First received: October 20, 2010
Last updated: March 9, 2011
Last verified: March 2011
  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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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)

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Maximum observed concentration within the dosing interval (Cmax) [ Time Frame: predose to day 7 of treatment period ] [ Designated as safety issue: No ]
  • Time for Cmax (Tmax) [ Time Frame: predose to day 7 of treatment period ] [ Designated as safety issue: No ]
  • Terminal half-life (t1/2) [ Time Frame: predose to day 7 of treatment period ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01226693     History of Changes
Other Study ID Numbers: A6631028
Study First Received: October 20, 2010
Last Updated: March 9, 2011
Health Authority: Singapore: Heath Science Authority

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

ClinicalTrials.gov processed this record on November 23, 2014