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Study Of PF-06817024 In Healthy Subjects, In Patients With Chronic Rhinosinusitis With Nasal Polyps And in Patients With Atopic Dermatitis

This study is currently recruiting participants.
Verified October 2017 by Pfizer
Sponsor:
ClinicalTrials.gov Identifier:
NCT02743871
First Posted: April 19, 2016
Last Update Posted: October 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose
The purpose of this study is to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06817024 in healthy volunteers, in participants with chronic rhinosinusitis, with nasal polyps and in participants with moderate-to-severe Atopic Dermatitis

Condition Intervention Phase
Healthy Chronic Rhinosinusitis With Nasal Polyps Atopic Dermatitis Biological: PF-06817024 Other: Placebo for PF-06817024 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Double-blind, Third-party Open, Placebo-controlled, Dose Escalating Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single And/or Multiple Intravenous And/or Subcutaneous Doses Of Pf-06817024 In Healthy Subjects Who May Be Mildly Atopic, Subjects With Chronic Rhinosinusitis With Nasal Polyps, And Subjects With Moderate-severe Atopic Dermatitis

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) [ Time Frame: Baseline (Day 0) up to discharge from study (minimally 211 days after last dose in Part 1) ]
    Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to discharge from study (minimally 211 days after last dose in Part 1) that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Drug PF-06817024 was assessed by the investigator (Yes/No).


Secondary Outcome Measures:
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Baseline (Day 0) up to discharge from study (minimally 211 days after last dose in Part 1) ]
    All Cohorts

  • Dose Normalized Maximum Observed Plasma Concentration (Cmax(dn)) [ Time Frame: Baseline (Day 0) up to discharge from study (minimally 211 days after last dose in Part 1) ]
    All Cohorts

  • Time to Reach Maximum Concentration (Tmax) [ Time Frame: Baseline (Day 0) up to discharge from study (minimally 211 days after last dose in Part 1) ]
    All Cohorts

  • Area Under the Concentration-Time Profile from Time Zero to Infinity (AUCinf) [ Time Frame: Baseline (Day 0) up to discharge from study (minimally 211 days after last dose in Part 1) ]
    Single Dose Cohorts

  • Area Under the Concentration-Time Curve Within Dosing Interval (AUCtau) [ Time Frame: Baseline (Day 0) up to discharge from study (minimally 211 days after last dose in Part 1) ]
    All Cohorts

  • Dose Normalized Area Under the Concentration-Time Curve Within Dosing Interval (AUCtau (dn)) [ Time Frame: Baseline (Day 0) up to discharge from study (minimally 211 days after last dose in Part 1) ]
    All Cohorts

  • Average Concentration Over Dosing Interval (Cav) [ Time Frame: Baseline (Day 0) up to discharge from study (minimally 211 days after last dose in Part 1) ]
    All Cohorts

  • Terminal Half Life (t1/2) [ Time Frame: Baseline (Day 0) up to discharge from study (minimally 211 days after last dose in Part 1) ]
    Single Dose Cohorts, Last (Second) Dose of Multiple Dose Cohorts

  • Mean Residence Time (MRT) [ Time Frame: Baseline (Day 0) up to discharge from study (minimally 211 days after last dose in Part 1) ]
    Single Dose Cohorts, Last (Second) Dose Multiple Dose Cohorts

  • Volume of Distribution at Steady State (Vss) [ Time Frame: Baseline (Day 0) up to discharge from study (minimally 211 days after last dose in Part 1) ]
    IV Cohorts

  • Clearance (CL) [ Time Frame: Baseline (Day 0) up to discharge from study (minimally 211 days after last dose in Part 1) ]
    IV Cohorts

  • Apparent Volume of Distribution (Vz/F) [ Time Frame: Baseline (Day 0) up to discharge from study (minimally 211 days after last dose in Part 1) ]
    SC Cohorts

  • Apparent Clearance (CL/F) [ Time Frame: Baseline (Day 0) up to discharge from study (minimally 211 days after last dose in Part 1) ]
    SC Cohorts

  • Minimum Observed Plasma Trough Concentration (Cmin) [ Time Frame: Baseline (Day 0) up to discharge from study (minimally 211 days after last dose in Part 1) ]
    Last (Second) Dose IV Cohorts, Last (Second) Dose SC Cohort

  • Observed Accumulated Ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) [ Time Frame: Baseline (Day 0) up to discharge from study (minimally 211 days after last dose in Part 1) ]
    Last (Second) Dose IV Cohorts, Last (Second) Dose SC Cohort

  • Observed Accumulated Ratio for Area Under the Concentration-Time Curve Without Dosing Interval (Rac(AUCtau)) [ Time Frame: Baseline (Day 0) up to discharge from study (minimally 211 days after last dose in Part 1) ]
    Last (Second) Dose IV Cohorts, Last (Second) Dose SC Cohort

  • Incidence of Anti-Drug Antibody (ADA) [ Time Frame: Baseline (Day 0) up to discharge from study (minimally 211 days after last dose in Part 1) ]
    All cohorts; The percentage of participants with positive ADA and neutralizing antibodies will be summarized for each treatment arm.

  • Area Under the Concentration-Time Profile from Time Zero to the Time of the Last Quantifiable Concentration (AUClast) [ Time Frame: Baseline (Day 0) up to discharge from study (minimally 211 days after last dose in Part 1) ]
    Single Dose Cohorts


Estimated Enrollment: 145
Actual Study Start Date: April 27, 2016
Estimated Study Completion Date: February 3, 2020
Estimated Primary Completion Date: February 3, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
10 mg of PF-06817024 or placebo
Biological: PF-06817024
Subjects will be given one dose of PF-06817024 intravenously
Other: Placebo for PF-06817024
Subjects will be given one dose of placebo for PF-06817024 intravenously
Experimental: Cohort 2
30 mg of PF-06817024 or placebo
Biological: PF-06817024
Subjects will be given one dose of PF-06817024 intravenously
Other: Placebo for PF-06817024
Subjects will be given one dose of placebo for PF-06817024 intravenously
Experimental: Cohort 3
100 mg of PF-06817024 or placebo
Biological: PF-06817024
Subjects will be given two doses of PF-06817024 intravenously
Other: Placebo for PF-06817024
Subjects will be given two doses of PF-06817024 intravenously
Experimental: Cohort 4
300 mg of PF-06817024 or placebo
Biological: PF-06817024
Subjects will be given one dose of PF-06817024 intravenously
Other: Placebo for PF-06817024
Subjects will be given one dose of placebo for PF-06817024 intravenously
Experimental: Cohort 5
1000 mg of PF-06817024 or placebo
Biological: PF-06817024
Subjects will be given one dose of PF-06817024 intravenously
Other: Placebo for PF-06817024
Subjects will be given one dose of placebo for PF-06817024 intravenously
Experimental: Cohort 6
2000 mg of PF-06817024 or placebo
Biological: PF-06817024
Subjects will be given one dose of PF-06817024 intravenously
Other: Placebo for PF-06817024
Subjects will be given one dose of placebo for PF-06817024 intravenously
Experimental: Cohort 7
30 mg subcutaneous dose of PF-06817024 or placebo
Biological: PF-06817024
Subjects will be given one dose of PF-06817024 subcutaneously
Other: Placebo for PF-06817024
Subjects will be given one dose of placebo for PF-06817024 subcutaneously
Experimental: Cohort 8
300 mg of PF-06817024 or placebo
Biological: PF-06817024
Subjects will be given one dose of PF-06817024 intravenously
Other: Placebo for PF-06817024
Subjects will be given one dose of placebo for PF-06817024 intravenously
Experimental: Cohort 9
IV dose to be determined of PF-06817024 or placebo
Biological: PF-06817024
Subjects will be given one dose of PF-06817024 intravenously
Other: Placebo for PF-06817024
Subjects will be given one dose of placebo for PF-06817024 intravenously
Experimental: Cohort 10
PF-06817024 or placebo
Biological: PF-06817024
Subjects will be given 2 doses intravenously
Other: Placebo for PF-06817024
Subjects will be given 2 doses intravenously
Experimental: Cohort 11
PF-06817024 or placebo
Biological: PF-06817024
Subjects will be given 2 doses intravenously
Other: Placebo for PF-06817024
Subjects will be given 2 doses intravenously
Experimental: Cohort 12
PF-06817024 or placebo
Biological: PF-06817024
Subjects will be given 2 doses intravenously
Other: Placebo for PF-06817024
Subjects will be given 2 doses intravenously
Experimental: Cohort 13
PF-06817024 or placebo
Biological: PF-06817024
Subjects will be given doses of PF-06817024 intravenously
Other: Placebo for PF-06817024
Subjects will be given doses of Placebo intravenously

Detailed Description:

The purpose of the study for Part 1 is to evaluate the safety and tolerability of PF-06817024 in healthy subjects.

The purpose of the study for Part 2 is to evaluate the safety and tolerability of PF-06817024 in patients with chronic rhinosinusitis with nasal polyps.

The purpose of the study for Part 3 is to evaluate the safety and tolerability of PF-06817024 in patients with moderate-to-severe Atopic Dermatitis

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Healthy male subjects, healthy female subjects of non-childbearing potential, 18-55 years of age (Part 1)
  • Male subjects, female subjects of non-childbearing potential, female subjects of childbearing potential with documented bilateral tubal ligation (tubes tied) or bilateral salpingectomy (tubes removed), 18-65 years of age, and 2 of the following symptoms: nasal congestion/obstruction, nasal discharge, face pain/pressure,or reduction/loss of smell (Part 2)
  • Male or female subjects between the ages of 18 and 70 years, inclusive with moderate-to-severe Atopic Dermatitis, agree to avoid prolonged exposure to the sun and not to use tanning booths, sun lamps, or other ultraviolet light sources during the study (Part 3)

Exclusion Criteria:

  • Clinically significant diseases (cardiac, psychiatric, autoimmune, renal, etc.), positive urine drug test, fever within 7 days of dosing, active infections within 28 days of dosing (Part 1 and 2 and 3)
  • History of allergic reaction to topical lidocaine, nasal surgery within 6 months (Part 2)
  • Exposure to live or attenuated vaccines, have skin conditions other than Atopic Dermatitis, use of JAK inhibitors and biologics (Part 3)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02743871


Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
United States, Connecticut
New Haven Clinical Research Unit Recruiting
New Haven, Connecticut, United States, 06511
Dermatology Physicians of Connecticut Recruiting
Shelton, Connecticut, United States, 06484
United States, Minnesota
Clinical Research Institute, Inc. Recruiting
Minneapolis, Minnesota, United States, 55402
Ear, Nose & Throat Specialty Care of Minnesota, P.A. Recruiting
Minneapolis, Minnesota, United States, 55404
Prism Research, LLC Recruiting
Saint Paul, Minnesota, United States, 55114
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02743871     History of Changes
Other Study ID Numbers: C0341001
First Submitted: April 15, 2016
First Posted: April 19, 2016
Last Update Posted: October 9, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests


Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:
FIH, Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, Atopic Dermatitis, Chronic Rhinosinusitis, Nasal Polyps

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Polyps
Sinusitis
Nasal Polyps
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pathological Conditions, Anatomical
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases