A First in Human Study to Evaluate Safety, Tolerability, and Pharmacology of PF-06826647 in Healthy Subjects and Subjects With Plaque Psoriasis

Pfizer

Status and phase: Completed; Phase 1

Conditions: Plaque Psoriasis

Treatments: Other: Placebo tablet; Other: Placebo oral solution/suspension; Drug: PF-06826647 oral suspension; Drug: PF-06826647 tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT03210961

C2501001

Details and patient eligibility

About

This first in human study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-06826647 in healthy subjects and subjects with plaque psoriasis.

Enrollment: 109 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Healthy Participants:

Inclusion Criteria:

• Healthy male subjects between ages of 18-55 years
• Healthy female subjects of non-childbearing potential between the ages of 18-55 years
• Body Mass Index (BMI) of 17.5 to 30.5kg/m2; and a total body weight >50kg (110lbs).
• No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
• (Optional) Japanese subjects who have four Japanese biologic grandparents born in Japan

Exclusion Criteria:

• 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)
• Pregnant female subjects; breastfeeding female subjects; female subjects of childbearing potential
• Fertile male subjects 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
• Have a clinically significant infection currently or within 6 months of first dose of study drug

Psoriasis Participants:

Inclusion Criteria:

• Healthy male subjects between ages of 18-65 years
• Healthy female subjects of non-childbearing potential between the ages of 18-65 years
• Have a diagnosis of plaque psoriasis for at least 6 months prior to first study dose
• Have plaque-type psoriasis covering at least 15% of total body surface area (BSA) at Day-1(prior to randomization in the study
• No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)

Exclusion Criteria:

• Currently have non-plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular psoriasis
• Have a clinically significant infection currently or within 6 months of first dose of study drug, or a history of chronic or recurrent infectious disease
• Pregnant female subjects; breastfeeding female subjects; female subjects of childbearing potential
• Fertile male subjects 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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

---

109 participants in 4 patient groups, including a placebo group

PF-06826647 tablet

Experimental group

Treatment:

Drug: PF-06826647 tablet

Placebo tablet

Placebo Comparator group

Treatment:

Other: Placebo tablet

PF-06826647 oral suspension

Experimental group

Treatment:

Drug: PF-06826647 oral suspension

Placebo oral solution/suspension

Placebo Comparator group

Treatment:

Other: Placebo oral solution/suspension