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

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Brussels, , B-1070 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01981681
Pfizer
Completed
A Phase 1 Study To Evaluate Tolerability, Safety, And Pharmacokinetics Of Topical PF-06263276 In Healthy Subjects

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A Phase 1 Study To Evaluate Tolerability, Safety, And Pharmacokinetics Of Topical PF-06263276 In Healthy Subjects
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Healthy
  • Drug: PF-06263726
    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.
  • Drug: PF-06263726
    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.
  • Drug: PF-06263726
    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.
  • Drug: Placebo
    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.
  • Drug: PF-06263726
    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.
  • Drug: Placebo
    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 1 Experimental Arm
    Intervention: Drug: PF-06263726
  • Experimental: Cohort 2 Experimental Arm
    Intervention: Drug: PF-06263726
  • Experimental: Cohort 3 Experimental Arm
    Intervention: Drug: PF-06263726
  • Placebo Comparator: Cohort 3 Placebo Arm
    Intervention: Drug: Placebo
  • Experimental: Cohort 4 Experimental Arm
    Intervention: Drug: PF-06263726
  • Placebo Comparator: Cohort 4 Placebo Arm
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
June 2014
June 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01981681
B5391002
2013-004231-68
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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