- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01981681
A Phase 1 Study To Evaluate Tolerability, Safety, And Pharmacokinetics Of Topical PF-06263276 In Healthy Subjects
July 15, 2014 updated by: Pfizer
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
47
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Brussels, Belgium, B-1070
- Pfizer Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Cohort 1 Experimental Arm
|
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.
Subjects will receive dose strength of 4% PF-06263276 (2.28 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.
Subjects will receive dose strength of 2% PF-06263276 (11.4 mg) in topical formulation (2.5 µL/cm2) to be applied twice daily to a 200 cm2 area on the back.
Subjects will receive dose strength of 4% PF-06263276 (22.8 mg) in topical formulation (2.5 µL/cm2) to be applied twice daily to a 200 cm2 area on the back.
|
EXPERIMENTAL: Cohort 2 Experimental Arm
|
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.
Subjects will receive dose strength of 4% PF-06263276 (2.28 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.
Subjects will receive dose strength of 2% PF-06263276 (11.4 mg) in topical formulation (2.5 µL/cm2) to be applied twice daily to a 200 cm2 area on the back.
Subjects will receive dose strength of 4% PF-06263276 (22.8 mg) in topical formulation (2.5 µL/cm2) to be applied twice daily to a 200 cm2 area on the back.
|
EXPERIMENTAL: Cohort 3 Experimental Arm
|
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.
Subjects will receive dose strength of 4% PF-06263276 (2.28 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.
Subjects will receive dose strength of 2% PF-06263276 (11.4 mg) in topical formulation (2.5 µL/cm2) to be applied twice daily to a 200 cm2 area on the back.
Subjects will receive dose strength of 4% PF-06263276 (22.8 mg) in topical formulation (2.5 µL/cm2) to be applied twice daily to a 200 cm2 area on the back.
|
PLACEBO_COMPARATOR: Cohort 3 Placebo Arm
|
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.
Subjects will receive dose strength of 4% PF-06263276 (22.8 mg) matching placebo in topical formulation (2.5 µL/cm2) to be applied twice daily to a 200 cm2 area on the back.
|
EXPERIMENTAL: Cohort 4 Experimental Arm
|
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.
Subjects will receive dose strength of 4% PF-06263276 (2.28 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.
Subjects will receive dose strength of 2% PF-06263276 (11.4 mg) in topical formulation (2.5 µL/cm2) to be applied twice daily to a 200 cm2 area on the back.
Subjects will receive dose strength of 4% PF-06263276 (22.8 mg) in topical formulation (2.5 µL/cm2) to be applied twice daily to a 200 cm2 area on the back.
|
PLACEBO_COMPARATOR: Cohort 4 Placebo Arm
|
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.
Subjects will receive dose strength of 4% PF-06263276 (22.8 mg) matching placebo in topical formulation (2.5 µL/cm2) to be applied twice daily to a 200 cm2 area on the back.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Draize toxicity assessment score.
Time Frame: Day 8, Day 28
|
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.
Time Frame: Day 23, Day 28
|
Day 23, Day 28
|
|
Changes from baseline in 12 lead electrocardiogram (ECG) parameters.
Time Frame: Day 23, Day 28
|
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.
Time Frame: Day 23, Day 28
|
Day 23, Day 28
|
|
Incidence and magnitude of treatment emergent clinical laboratory abnormalities including hematology, chemistry, fasting glucose, urinalysis.
Time Frame: Day 23, Day 28
|
Day 23, Day 28
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cohorts 3 and 4: Maximum Observed Plasma Concentration (Cmax)
Time Frame: Day 1, Day 14
|
Day 1, Day 14
|
|
Cohorts 3 and 4: Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame: Day 1, Day 14
|
Day 1, Day 14
|
|
Cohorts 3 and 4: Area Under the Curve From Time Zero to 12 hours [AUC (0-12)]
Time Frame: Day 1, Day 14
|
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
|
Day 1, Day 14
|
Cohorts 3 and 4: Dose-Normalized Area Under the Curve From Time Zero to 12 hours [AUC (0-12)]
Time Frame: Day 1, Day 14
|
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
|
Day 1, Day 14
|
Cohorts 3 and 4: Dose-Normalized Maximum Observed Plasma Concentration [Cmax (dn)]
Time Frame: Day 1, Day 14
|
Day 1, Day 14
|
|
Cohorts 3 and 4: Plasma Decay Half-Life (t1/2)
Time Frame: Day 14
|
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
|
Day 14
|
Cohorts 3 and 4: Apparent Volume of Distribution (Vz/F)
Time Frame: Day 14
|
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
|
Day 14
|
Cohorts 3 and 4: Apparent Oral Clearance (CL/F)
Time Frame: Day 14
|
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
Clearance was estimated from population pharmacokinetic (PK) modeling.
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
|
Day 14
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2013
Primary Completion (ACTUAL)
June 1, 2014
Study Completion (ACTUAL)
June 1, 2014
Study Registration Dates
First Submitted
November 5, 2013
First Submitted That Met QC Criteria
November 5, 2013
First Posted (ESTIMATE)
November 11, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
July 17, 2014
Last Update Submitted That Met QC Criteria
July 15, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- B5391002
- 2013-004231-68
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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