A Phase 1 Study To Evaluate Tolerability, Safety, And Pharmacokinetics Of Topical PF-06263276 In Healthy Subjects

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: PF-06263726

Study type: Interventional

Funder types: Industry

Identifiers

NCT01981681

B5391002

2013-004231-68

Details and patient eligibility

About

PF-06263276 is a first in class inhibitor of the Janus kinase (JAK) enzymes 1, 2, 3 and tyrosine kinase 2 (TYK2) that is being developed for the treatment of chronic plaque psoriasis. The goal of the study is to assess the safety, local tolerability, and pharmacokinetics in healthy subjects.

Enrollment: 47 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests.
• Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• Subjects willing to avoid tanning beds and sun exposure of the back during the study.

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 application).
• Subjects with any active skin condition at the application site possibly affecting drug absorption (e.g. rash, sun burn, scars, tattoos).
• Subjects with a Draize score >0 of the test area (back) immediately prior to first treatment application.
• Subjects using topical prescription or nonprescription drugs/over the counter preparations on the back within 14 days of the first treatment application.
• Subjects not willing to avoid application of treatmentssuch as lotions or creams to the back throughout the study until follow-up.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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47 participants in 6 patient groups, including a placebo group

Cohort 1 Experimental Arm

Experimental group

Treatment:

Drug: PF-06263726

Drug: PF-06263726

Drug: PF-06263726

Drug: PF-06263726

Cohort 2 Experimental Arm

Experimental group

Treatment:

Drug: PF-06263726

Drug: PF-06263726

Drug: PF-06263726

Drug: PF-06263726

Cohort 3 Experimental Arm

Experimental group

Treatment:

Drug: PF-06263726

Drug: PF-06263726

Drug: PF-06263726

Drug: PF-06263726

Cohort 3 Placebo Arm

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

Cohort 4 Experimental Arm

Experimental group

Treatment:

Drug: PF-06263726

Drug: PF-06263726

Drug: PF-06263726

Drug: PF-06263726

Cohort 4 Placebo Arm

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo