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

NCT01981681 | Completed Phase 1

• 2 other identifiers: B53910022013-004231-68
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Phase 1; Randomized; Placebo-Controlled; Multiple Dose Escalation; Tolerability; Safety; PK; Topical; Healthy; PF-06263276

Outcome Measures

Primary Outcomes (5)

• Draize toxicity assessment score.

  Changes from baseline on Draize toxicity assessment score.

  Day 8, Day 28

• Changes from baseline vital signs (blood pressure, pulse rate, oral temperature and respiration rate) and physical examinations.

  Day 23, Day 28

• Changes from baseline in 12 lead electrocardiogram (ECG) parameters.

  Quantitative changes in ECG intervals.

  Day 23, Day 28

• Incidence and severity of treatment emergent adverse events and withdrawals due to treatment emergent adverse events.

  Day 23, Day 28

• Incidence and magnitude of treatment emergent clinical laboratory abnormalities including hematology, chemistry, fasting glucose, urinalysis.

  Day 23, Day 28

Secondary Outcomes (8)

• Cohorts 3 and 4: Maximum Observed Plasma Concentration (Cmax)

  Day 1, Day 14

• Cohorts 3 and 4: Time to Reach Maximum Observed Plasma Concentration (Tmax)

  Day 1, Day 14

• Cohorts 3 and 4: Area Under the Curve From Time Zero to 12 hours [AUC (0-12)]

  Day 1, Day 14

• Cohorts 3 and 4: Dose-Normalized Area Under the Curve From Time Zero to 12 hours [AUC (0-12)]

  Day 1, Day 14

• Cohorts 3 and 4: Dose-Normalized Maximum Observed Plasma Concentration [Cmax (dn)]

  Day 1, Day 14

Study Arms (6)

Cohort 1 Experimental Arm

EXPERIMENTAL

Drug: PF-06263726

Cohort 2 Experimental Arm

EXPERIMENTAL

Drug: PF-06263726

Cohort 3 Experimental Arm

EXPERIMENTAL

Drug: PF-06263726

Cohort 3 Placebo Arm

PLACEBO COMPARATOR

Drug: Placebo

Cohort 4 Experimental Arm

EXPERIMENTAL

Drug: PF-06263726

Cohort 4 Placebo Arm

PLACEBO COMPARATOR

Drug: Placebo

Interventions

PF-06263726 DRUG

Subjects will receive dose strength of 2% PF-06263276 (1.14 mg) and matching placebo in topical formulation (2.5 µL/cm2) to be applied twice daily to two separate contralateral 20 cm2 areas on the back.

Cohort 1 Experimental Arm

Placebo DRUG

Subjects will receive dose strength of 2% PF-06263276 (11.4 mg) matching placebo in topical formulation (2.5 µL/cm2) to be applied twice daily to a 200 cm2 area on the back.

Cohort 3 Placebo Arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Brussels, B-1070, Belgium

Location

Related Links

• To obtain contact information for a study center near you, click here.

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2013
• First Posted: November 11, 2013
• Study Start: November 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 17, 2014

Record last verified: 2014-07

Locations

BE (1)