Status:
COMPLETED
A Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study Of PF-06700841, With Bioavailability/Food Effect Investigation
Lead Sponsor:
Pfizer
Conditions:
Plaque Psoriasis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The main purpose of the study is to determine if PF-06700841 is safe and well tolerated when administered to humans. A secondary purpose is to assess what the body does to PF-06700841 and to assess wh...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria for Healthy Subject Cohorts:
- Healthy male subjects and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive
- No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
- Key Inclusion Criteria for Psoriasis Subject Cohorts:
- Male subjects and/or female subjects of non-childbearing potential with a diagnosis of plaque psoriasis who are between the ages of 18 and 65 years, inclusive
- Have a diagnosis of plaque psoriasis for at least 6 months prior to first study dose
Exclusion
- Key Exclusion Criteria for Healthy Subject Cohorts:
- Evidence or 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)
- Males of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product
- Key Exclusion Criteria for Psoriasis Subject Cohorts:
- Currently have non plaque forms of psoriasis, (eg, erythrodermic, guttate, or pustular psoriasis).
- Have current drug induced psoriasis, eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, antimalarial drugs or lithium
- Males of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT02310750
Start Date
November 1 2014
End Date
February 1 2016
Last Update
March 8 2017
Active Locations (1)
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1
Anaheim Clinical Trials, LLC
Anaheim, California, United States, 92801