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

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)

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: PH-797804 material sparing tablet; Drug: PH-797804 Phase2b/3 with sodium lauryl sulphate; Drug: PH-797804 Phase2b/3 without sodium lauryl sulphate

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 188770
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 material sparing tablet; oral, 6mg, single dose; Drug: PH-797804 Phase2b/3 with sodium lauryl sulphate; 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 material sparing tablet; oral, 6mg, single dose; Drug: PH-797804 Phase2b/3 without sodium lauryl sulphate; oral, 6mg, single dose
Experimental: Sequence 5; 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)	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)	predose to day 7 of treatment period
Maximum observed concentration within the dosing interval (Cmax)	predose to day 7 of treatment period
Time for Cmax (Tmax)	predose to day 7 of treatment period
Terminal half-life (t1/2)	predose to day 7 of treatment period

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: October 20, 2010
• First Submitted That Met QC Criteria: October 20, 2010
• First Posted (Estimate): October 22, 2010

Study Record Updates

• Last Update Posted (Estimate): March 10, 2011
• Last Update Submitted That Met QC Criteria: March 9, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: pharmacokinetic; single dose bioequivalence study; balanced incomplete block design; PH-797804; P38 kinase inhibitor
• Other Study ID Numbers: A6631028