Status:
COMPLETED
A Study In Healthy Volunteers To Assess The Safety, Tolerability, And Relative Oral Bioavailability Of Three Formulations Of PH-797804
Lead Sponsor:
Pfizer
Conditions:
Healthy
Eligibility:
All Genders
21-55 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01226693
Start Date
November 1 2010
End Date
March 1 2011
Last Update
March 10 2011
Active Locations (1)
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1
Pfizer Investigational Site
Singapore, Singapore, 188770