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Trial record 1 of 1 for:    NCT02743871
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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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02743871
Recruitment Status : Active, not recruiting
First Posted : April 19, 2016
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE April 15, 2016
First Posted Date  ICMJE April 19, 2016
Last Update Posted Date September 6, 2019
Actual Study Start Date  ICMJE April 27, 2016
Estimated Primary Completion Date February 14, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2017)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: April 15, 2016)
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) [ Time Frame: Baseline (Day 0) up to 211 days after last dose of study medication ]
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 211 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Drug PF-06817024 was assessed by the investigator (Yes/No).
Change History Complete list of historical versions of study NCT02743871 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2018)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2016)
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Baseline (Day 0) up to 211 days after last dose of study medication ]
  • Dose Normalized Maximum Observed Plasma Concentration (Cmax(dn)) [ Time Frame: Baseline (Day 0) up to 211 days after last dose of study medication ]
  • Time to Reach Maximum Concentration (Tmax) [ Time Frame: Baseline (Day 0) up to 211 days after last dose of study medication ]
  • Area Under the Concentration-Time Profile from Time Zero to Infinity (AUCinf) [ Time Frame: Baseline (Day 0) up to 211 days after last dose of study medication ]
  • Area Under the Concentration-Time Curve Within Dosing Interval (AUCtau) [ Time Frame: Baseline (Day 0) up to 211 days after last dose of study medication ]
  • Dose Normalized Area Under the Concentration-Time Curve Within Dosing Interval (AUCtau (dn)) [ Time Frame: Baseline (Day 0) up to 211 days after last dose of study medication ]
  • Average Concentration Over Dosing Interval (Cav) [ Time Frame: Baseline (Day 0) up to 211 days after last dose of study medication ]
  • Terminal Half Life (t1/2) [ Time Frame: Baseline (Day 0) up to 211 days after last dose of study medication ]
    Single Dose IV Cohorts, Last (Second) Dose IV Cohorts, Last (Second) Dose SC Cohort
  • Mean Residence Time (MRT) [ Time Frame: Baseline (Day 0) up to 211 days after last dose of study medication ]
    Single Dose IV Cohorts, Last (Second) Dose IV Cohorts, Last (Second) Dose SC Cohort
  • Volume of Distribution at Steady State (Vss) [ Time Frame: Baseline (Day 0) up to 211 days after last dose of study medication ]
    Single Dose IV Cohorts, Last (Second) Dose IV Cohorts
  • Clearance (CL) [ Time Frame: Baseline (Day 0) up to 211 days after last dose of study medication ]
    Single Dose IV Cohorts, Last (Second) Dose IV Cohorts
  • Apparent Volume of Distribution (Vz/F) [ Time Frame: Baseline (Day 0) up to 211 days after last dose of study medication ]
    Last (Second) Dose SC Cohort
  • Apparent Clearance (CL/F) [ Time Frame: Baseline (Day 0) up to 211 days after last dose of study medication ]
    Last (Second) Dose SC Cohort
  • Minimum Observed Plasma Trough Concentration (Cmin) [ Time Frame: Baseline (Day 0) up to 211 days after last dose of study medication ]
    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 211 days after last dose of study medication ]
    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 211 days after last dose of study medication ]
    Last (Second) Dose IV Cohorts, Last (Second) Dose SC Cohort
  • Incidence of Anti-Drug Antibody (ADA) [ Time Frame: Baseline (Day 0) up to 211 days after last dose of study medication ]
    The percentage of participants with positive ADA and neutralizing antibodies will be summarized for each treatment arm.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Of PF-06817024 In Healthy Subjects, In Patients With Chronic Rhinosinusitis With Nasal Polyps And in Patients With Atopic Dermatitis
Official Title  ICMJE 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
Brief Summary 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
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Healthy
  • Chronic Rhinosinusitis With Nasal Polyps
  • Atopic Dermatitis
Intervention  ICMJE
  • 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
  • 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
  • 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
  • Biological: PF-06817024
    Subjects will be given 2 doses intravenously
  • Other: Placebo for PF-06817024
    Subjects will be given 2 doses intravenously
  • 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
Study Arms  ICMJE
  • Experimental: Cohort 1
    10 mg of PF-06817024 or placebo
    Interventions:
    • Biological: PF-06817024
    • Other: Placebo for PF-06817024
  • Experimental: Cohort 2
    30 mg of PF-06817024 or placebo
    Interventions:
    • Biological: PF-06817024
    • Other: Placebo for PF-06817024
  • Experimental: Cohort 3
    100 mg of PF-06817024 or placebo
    Interventions:
    • Biological: PF-06817024
    • Other: Placebo for PF-06817024
  • Experimental: Cohort 4
    300 mg of PF-06817024 or placebo
    Interventions:
    • Biological: PF-06817024
    • Other: Placebo for PF-06817024
  • Experimental: Cohort 5
    1000 mg of PF-06817024 or placebo
    Interventions:
    • Biological: PF-06817024
    • Other: Placebo for PF-06817024
  • Experimental: Cohort 6
    2000 mg of PF-06817024 or placebo
    Interventions:
    • Biological: PF-06817024
    • Other: Placebo for PF-06817024
  • Experimental: Cohort 7
    30 mg subcutaneous dose of PF-06817024 or placebo
    Interventions:
    • Biological: PF-06817024
    • Other: Placebo for PF-06817024
  • Experimental: Cohort 8
    300 mg of PF-06817024 or placebo
    Interventions:
    • Biological: PF-06817024
    • Other: Placebo for PF-06817024
  • Experimental: Cohort 9
    IV dose to be determined of PF-06817024 or placebo
    Interventions:
    • Biological: PF-06817024
    • Other: Placebo for PF-06817024
  • Experimental: Cohort 10
    PF-06817024 or placebo
    Interventions:
    • Biological: PF-06817024
    • Other: Placebo for PF-06817024
  • Experimental: Cohort 11
    PF-06817024 or placebo
    Interventions:
    • Biological: PF-06817024
    • Other: Placebo for PF-06817024
  • Experimental: Cohort 12
    PF-06817024 or placebo
    Interventions:
    • Biological: PF-06817024
    • Other: Placebo for PF-06817024
  • Experimental: Cohort 13
    PF-06817024 or placebo
    Interventions:
    • Biological: PF-06817024
    • Other: Placebo for PF-06817024
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 3, 2019)
97
Original Estimated Enrollment  ICMJE
 (submitted: April 15, 2016)
110
Estimated Study Completion Date  ICMJE February 14, 2021
Estimated Primary Completion Date February 14, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 75 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02743871
Other Study ID Numbers  ICMJE C0341001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP