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

• ClinicalTrials.gov Identifier: NCT01226693
• Recruitment Status: Completed
• First Posted: October 22, 2010
• Last Update Posted: March 10, 2011
• Sponsor: Pfizer
• Information provided by: Pfizer

Study Description

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.

Condition or disease	Intervention/treatment	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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 18 participants
• 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)
• Study Start Date: November 2010
• Actual Primary Completion Date: March 2011
• Actual Study Completion Date: March 2011

Arms and Interventions

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 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

Outcome Measures

Primary Outcome Measures :

1. Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf) [ Time Frame: predose to day 7 of treatment period ]
2. 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 ]
3. Maximum observed concentration within the dosing interval (Cmax) [ Time Frame: predose to day 7 of treatment period ]
4. Time for Cmax (Tmax) [ Time Frame: predose to day 7 of treatment period ]
5. Terminal half-life (t1/2) [ Time Frame: predose to day 7 of treatment period ]

Eligibility Criteria

• 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

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:

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

• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
• ClinicalTrials.gov Identifier: NCT01226693
• Other Study ID Numbers: A6631028
• 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