A Study In Healthy Volunteers To Assess The Safety, Tolerability, And Relative Oral Bioavailability Of Three Formulations Of PH-797804
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ClinicalTrials.gov Identifier: NCT01226693 |
Recruitment Status :
Completed
First Posted : October 22, 2010
Last Update Posted : March 10, 2011
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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 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 |
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 |
- 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 ]

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

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
Singapore | |
Pfizer Investigational Site | |
Singapore, Singapore, 188770 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
ClinicalTrials.gov Identifier: | NCT01226693 |
Other Study ID Numbers: |
A6631028 |
First Posted: | October 22, 2010 Key Record Dates |
Last Update Posted: | March 10, 2011 |
Last Verified: | March 2011 |
pharmacokinetic single dose bioequivalence study balanced incomplete block design PH-797804 P38 kinase inhibitor |