Clinical trial NCT01981681: A Phase 1 Study To Evaluate Tolerability, Safety, And Pharmacokinetics Of Topical PF-06263276 In Healthy Subjects
Official title: A Phase 1, Randomized, Third-Party Open, Placebo-Controlled, Multiple Dose Escalation, Parallel Group Study To Evaluate Local Tolerability, Safety And Pharmacokinetics Of Topically Applied PF-06263276 In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Phase 1
Randomized
Placebo-Controlled
Multiple Dose Escalation
Tolerability
Safety
PK
Topical
Healthy
PF-06263276
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-11-11
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Draize toxicity assessment score.
timeFrame: Day 8, Day 28
measure: Changes from baseline vital signs (blood pressure, pulse rate, oral temperature and respiration rate) and physical examinations.
timeFrame: Day 23, Day 28
measure: Changes from baseline in 12 lead electrocardiogram (ECG) parameters.
timeFrame: Day 23, Day 28
measure: Incidence and severity of treatment emergent adverse events and withdrawals due to treatment emergent adverse events.
timeFrame: Day 23, Day 28
measure: Incidence and magnitude of treatment emergent clinical laboratory abnormalities including hematology, chemistry, fasting glucose, urinalysis.
timeFrame: Day 23, Day 28
Secondary outcomes:
measure: Cohorts 3 and 4: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Day 1, Day 14
measure: Cohorts 3 and 4: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: Day 1, Day 14
measure: Cohorts 3 and 4: Area Under the Curve From Time Zero to 12 hours [AUC (0-12)]
timeFrame: Day 1, Day 14
measure: Cohorts 3 and 4: Dose-Normalized Area Under the Curve From Time Zero to 12 hours [AUC (0-12)]
timeFrame: Day 1, Day 14
measure: Cohorts 3 and 4: Dose-Normalized Maximum Observed Plasma Concentration [Cmax (dn)]
timeFrame: Day 1, Day 14
measure: Cohorts 3 and 4: Plasma Decay Half-Life (t1/2)
timeFrame: Day 14
measure: Cohorts 3 and 4: Apparent Volume of Distribution (Vz/F)
timeFrame: Day 14
measure: Cohorts 3 and 4: Apparent Oral Clearance (CL/F)
timeFrame: Day 14
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: