A Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study Of PF-06700841, With Bioavailability/Food Effect Investigation
| Status: | Completed |
|---|---|
| Conditions: | Psoriasis |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | November 2014 |
| End Date: | February 2016 |
A Phase 1, Within Cohort, Randomized, Double Blind, Third-party Open, Placebo-controlled, Single- And Multiple Dose Escalation, Parallel Group Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06700841 In Healthy Subjects And Subjects With Plaque Psoriasis And Bioavailability Of A Tablet Formulation Relative To Suspension Formulation And The Effect Of Food On A Tablet Formulation Of Pf-06700841
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).
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).
Inclusion Criteria:
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 Criteria:
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
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