Healthy
Conditions
Keywords
pharmacokinetic, single dose bioequivalence study, balanced incomplete block design, PH-797804, P38 kinase inhibitor
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.
Interventions
DRUGPH-797804 material sparing tablet
oral, 6mg, single dose
DRUGPH-797804 Phase2b/3 with sodium lauryl sulphate
oral, 6mg, single dose
DRUGPH-797804 Phase2b/3 without sodium lauryl sulphate
oral, 6mg, single dose
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
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.
Design outcomes
Primary
| 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 |
Countries
Singapore
Outcome results
None listed