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Study Of PF-06817024 In Healthy Subjects And In Patients With Chronic Rhinosinusitis With Nasal Polyps

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT02743871
First received: April 15, 2016
Last updated: August 15, 2017
Last verified: August 2017
  Purpose
The purpose of this study is to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06817024 in healthy volunteers who may be mildly atopic and in participants with chronic rhinosinusitis with nasal polyps

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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 Multiple Intravenous And Subcutaneous Doses Of Pf-06817024 In Healthy Subjects Who May Be Mildly Atopic And Of Single Doses Of Pf-06817024 In Patients With Chronic Rhinosinusitis With Nasal Polyps

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 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).


Secondary Outcome Measures:
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Baseline (Day 0) up to 211 days after last dose of study medication ]
    All Cohorts

  • Dose Normalized Maximum Observed Plasma Concentration (Cmax(dn)) [ Time Frame: Baseline (Day 0) up to 211 days after last dose of study medication ]
    All Cohorts

  • Time to Reach Maximum Concentration (Tmax) [ Time Frame: Baseline (Day 0) up to 211 days after last dose of study medication ]
    All Cohorts

  • 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 ]
    Single Dose Cohorts

  • 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 ]
    All Cohorts

  • 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 ]
    All Cohorts

  • Average Concentration Over Dosing Interval (Cav) [ Time Frame: Baseline (Day 0) up to 211 days after last dose of study medication ]
    All Cohorts

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

  • Mean Residence Time (MRT) [ Time Frame: Baseline (Day 0) up to 211 days after last dose of study medication ]
    Single Dose Cohorts, Last (Second) Dose Multiple Dose Cohorts

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

  • Clearance (CL) [ Time Frame: Baseline (Day 0) up to 211 days after last dose of study medication ]
    IV Cohorts

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

  • Apparent Clearance (CL/F) [ Time Frame: Baseline (Day 0) up to 211 days after last dose of study medication ]
    SC Cohorts

  • 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.

  • 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 211 days after last dose of study medication ]
    Single Dose Cohorts


Estimated Enrollment: 99
Actual Study Start Date: April 27, 2016
Estimated Study Completion Date: November 8, 2019
Estimated Primary Completion Date: November 8, 2019 (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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
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)

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)
  • History of allergic reaction to topical lidocaine, nasal surgery within 6 months (Part 2)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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
Study First Received: April 15, 2016
Last Updated: August 15, 2017

Keywords provided by Pfizer:
FIH, Pharmacokinetics

Additional relevant MeSH terms:
Polyps
Sinusitis
Nasal Polyps
Pathological Conditions, Anatomical
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on August 18, 2017