A Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study Of PF-06700841, With Bioavailability/Food Effect Investigation
Completed · Phase 1 · Has a placebo group
Conditions studied: Plaque Psoriasis
In brief
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 what PF-06700841 does to the body when given as single and multiple doses. The pharmacokinetic properties of different forms of PF-06700841 may be studied (tablet and solution/suspension forms).
Key facts
- Study ID
- NCT02310750
- Run by
- Pfizer
- People needed
- 96
- Starts
- 2014-11-01
- Expected to finish
- 2016-02-01
- Last updated by the study team
- 2017-03-08
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Anaheim Clinical Trials, LLC — Anaheim, California, United States
Full record on ClinicalTrials.gov
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