A Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study Of PF-06700841, With Bioavailability/Food Effect Investigation

Pfizer

Status and phase: Completed; Phase 1

Conditions: Plaque Psoriasis

Treatments: Drug: PF-06700841 oral solution/suspension; Other: Placebo; Drug: PF-06700841 tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT02310750

B7931001

Details and patient eligibility

About

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).

Enrollment: 96 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

96 participants in 3 patient groups, including a placebo group

PF-06700841 Oral Solution/Suspension

Experimental group

Treatment:

Drug: PF-06700841 oral solution/suspension

PF-06700841 Tablet

Experimental group

Treatment:

Drug: PF-06700841 tablet

Placebo

Placebo Comparator group

Description:

Oral placebo comparator for the healthy subject single and multiple ascending dose periods, and the psoriasis multiple dose period. No placebo used for the bioavailability investigation.

Treatment:

Other: Placebo