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

NCT02743871 | Completed Phase 1 Results FDA Drug

• 1 other identifier: C0341001
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 20

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

Conditions

Healthy; Chronic Rhinosinusitis With Nasal Polyps; Atopic Dermatitis

Keywords

FIH, Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, Atopic Dermatitis, Chronic Rhinosinusitis, Nasal Polyps

Outcome Measures

Primary Outcomes (21)

• Number of Participants With All-causality Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Part 1

  An adverse event (AE) was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state. An SAE was any untoward medical occurrence at any dose that: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect.

  From Study Day 1 (baseline) up to Day 421 (Cohort 1 and 2), Day 601 (Cohort 3), Day 691 (Cohort 4), Day 781 (Cohort 5), and Day 511 (Cohort 7).

• Number of Participants With Treatment-Related TEAEs and SAEs in Part 1

  An AE was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state. An SAE was any untoward medical occurrence at any dose that: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect. The causality of TEAEs and SAEs was determined by the investigator.

  From Study Day 1 (baseline) up to Day 421 (Cohort 1 and 2), Day 601 (Cohort 3), Day 691 (Cohort 4), Day 781 (Cohort 5), and Day 511 (Cohort 7).

• Number of All-Causality TEAEs According to Severity in Part 1

  An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state. TEAE was assessed by the investigator according to severity; Mild: did not interfere with participant's usual function; moderate: interfered to some extent with participant's usual function; severe: interfered significantly with participant's usual function.

  From Study Day 1 (baseline) up to Day 421 (Cohort 1 and 2), Day 601 (Cohort 3), Day 691 (Cohort 4), Day 781 (Cohort 5), and Day 511 (Cohort 7).

• Number of Participants With Permanent Discontinuation Due to TEAEs in Part 1

  An AE was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state.

  From Study Day 1 (baseline) up to Day 421 (Cohort 1 and 2), Day 601 (Cohort 3), Day 691 (Cohort 4), Day 781 (Cohort 5), and Day 511 (Cohort 7).

• Number of Participants With All-Causality TEAEs and SAEs in Part 2

  An AE was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state. An SAE was any untoward medical occurrence at any dose that: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect.

  From Study Day 1 (baseline) up to Day 691.

• Number of Participants With Treatment-Related TEAEs and SAEs in Part 2

  An AE was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state. An SAE was any untoward medical occurrence at any dose that: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect. The causality of TEAEs and SAEs was determined by the investigator.

  From Study Day 1 (baseline) up to Day 691.

• Number of All-Causality TEAEs According to Severity in Part 2

  An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state. TEAE was assessed by the investigator according to severity; Mild: did not interfere with participant's usual function; moderate: interfered to some extent with participant's usual function; severe: interfered significantly with participant's usual function.

  From Study Day 1 (baseline) up to Day 691.

• Number of Participants With Permanent Discontinuation Due to TEAEs in Part 2

  An AE was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state.

  From Study Day 1 (baseline) up to Day 691.

• Number of Participants With All-Causality TEAEs and SAEs in Part 3

  An AE was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state. An SAE was any untoward medical occurrence at any dose that: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect.

  From Study Day 1 (baseline) up to Day 1105.

• Number of Participants With Treatment-Related TEAEs and SAEs in Part 3

  An AE was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state. An SAE was any untoward medical occurrence at any dose that: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect. The causality of TEAEs and SAEs was determined by the investigator.

  From Study Day 1 (baseline) up to Day 1105.

• Number of All-Causality TEAEs According to Severity in Part 3

  An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state. TEAE was assessed by the investigator according to severity; Mild: did not interfere with participant's usual function; moderate: interfered to some extent with participant's usual function; severe: interfered significantly with participant's usual function.

  From Study Day 1 (baseline) up to Day 1105.

• Number of Participants With Permanent Discontinuation Due to TEAEs in Part 3

  An AE was any untoward medical occurrence in a clinical investigation participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state.

  From Study Day 1 (baseline) up to Day 1105.

• Number of Participants With Clinically Significant Laboratory Abnormalities in Hematology, Chemistry, and Urinalysis in Part 1

  Hematology parameters included hemoglobin, hematocrit, red blood cell, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet and white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes. Chemistry parameters included blood urea nitrogen, glucose (fasting), calcium, sodium, potassium, chloride, bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein. Urine parameters included pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy. Clinical significance was judged by the investigator and those met the criteria of AE are listed here. Clinically significant laboratory abnormalities reported for at least 1 participant in the whole study are presented here.

  Part 1 single-dose cohorts: from Study Day 1 (baseline) up to Day 211. Part 1 multiple-dose cohorts: from Study Day 1 (baseline) up to Day 241.

• Number of Participants With Clinically Significant Laboratory Abnormalities in Hematology, Chemistry, and Urinalysis in Part 2

  Hematology parameters included hemoglobin, hematocrit, red blood cell, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet and white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes. Chemistry parameters included blood urea nitrogen, glucose (fasting), calcium, sodium, potassium, chloride, bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein. Urine parameters included pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy. Clinical significance was judged by the investigator and those met the criteria of AE are listed here. Clinically significant laboratory abnormalities reported for at least 1 participant in the whole study are presented here.

  Part 2: from Study Day 1 (baseline) up to Day 211.

• Number of Participants With Clinically Significant Laboratory Abnormalities in Hematology, Chemistry, and Urinalysis in Part 3

  Hematology parameters included hemoglobin, hematocrit, red blood cell, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet and white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes. Chemistry parameters included blood urea nitrogen, glucose (fasting), calcium, sodium, potassium, chloride, bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein. Urine parameters included pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy. Clinical significance was judged by the investigator and those met the criteria of AE are listed here. Clinically significant laboratory abnormalities reported for at least 1 participant in the whole study are presented here.

  Part 3: from Study Day 1 (baseline) up to Day 966.

• Number of Participants With Vital Sign Abnormalities in Part 1

  Criteria for abnormality in vital signs: supine pulse rate \<40 beats per minute (bpm) or \>120 bpm; supine diastolic blood pressure (DBP) \<50 mmHg, maximum increase or decrease from baseline of \>=20 mmHg; supine systolic blood pressure (SBP) \<90 mmHg, maximum increase or decrease from baseline of \>=30 mmHg. Baseline was defined as the last measurement prior to the first dosing. Vital sign abnormalities reported for at least 1 participant are presented here.

  Study Day 1 (baseline) up to end of study (Study Day 211 for Part 1 SD cohorts, and Study Day 241 for Part 1 MD cohorts).

• Number of Participants With Vital Sign Abnormalities in Part 2

  Criteria for abnormality in vital signs: supine pulse rate \<40 bpm or \>120 bpm; supine DBP \<50 mmHg, maximum increase or decrease from baseline of \>=20 mmHg; supine SBP \<90 mmHg, maximum increase or decrease from baseline of \>=30 mmHg. Baseline was defined as the last measurement prior to the first dosing. Vital sign abnormalities reported for at least 1 participant are presented here.

  Study Day 1 (baseline) up to end of study (Study Day 211).

• Number of Participants With Vital Sign Abnormalities in Part 3

  Criteria for abnormality in vital signs: supine pulse rate \<40 bpm or \>120 bpm; supine DBP \<50 mmHg, maximum increase or decrease from baseline of \>=20 mmHg; supine SBP \<90 mmHg, maximum increase or decrease from baseline of \>=30 mmHg. Baseline was defined as the last measurement prior to the first dosing. Vital sign abnormalities reported for at least 1 participant are presented here.

  Study Day 1 (baseline) up to end of study (Study Day 337).

• Number of Participants With Electrocardiogram (ECG) Abnormalities in Part 1

  ECG abnormalities criteria included: 1) maximum QTc interval adjusted according Fridericia formula (QTcF) (msec): 450\<= QTcF \<480, 480\<= QTcF \<500, and QTcF \>=500; QTcF maximum increase from baseline(msec): 30\<= change \<60, and change \>=60; 2) maximum PR interval (msec): \>=300; PR increase from baseline (msec): baseline \>200 with 25% increase at maximum, baseline \<=200 with 50% increase at maximum; 3) maximum QRS (msec): \>=140; QRS increase from baseline (msec) \>=50%. Baseline was defined as the average of the last triplicate measurement prior to the first dosing. ECG abnormalities reported for at least 1 participant are presented here.

  Study Day 1 (baseline) up to end of study (Study Day 211 for Part 1 SD cohorts, and Study Day 241 for Part 1 MD cohorts).

• Number of Participants With ECG Abnormalities in Part 2

  ECG abnormalities criteria included: 1) maximum QTc interval adjusted according Fridericia formula (QTcF) (msec): 450\<= QTcF \<480, 480\<= QTcF \<500, and QTcF \>=500; QTcF maximum increase from baseline(msec): 30\<= change \<60, and change \>=60; 2) maximum PR interval (msec): \>=300; PR increase from baseline (msec): baseline \>200 with 25% increase at maximum, baseline \<=200 with 50% increase at maximum; 3) maximum QRS (msec): \>=140; QRS increase from baseline (msec) \>=50%. Baseline was defined as the average of the last triplicate measurement prior to the first dosing. ECG abnormalities reported for at least 1 participant are presented here.

  Study Day 1 (baseline) up to end of study (Study Day 211).

• Number of Participants With ECG Abnormalities in Part 3

  ECG abnormalities criteria included: 1) maximum QTc interval adjusted according Fridericia formula (QTcF) (msec): 450\<= QTcF \<480, 480\<= QTcF \<500, and QTcF \>=500; QTcF maximum increase from baseline(msec): 30\<= change \<60, and change \>=60; 2) maximum PR interval (msec): \>=300; PR increase from baseline (msec): baseline \>200 with 25% increase at maximum, baseline \<=200 with 50% increase at maximum; 3) maximum QRS (msec): \>=140; QRS increase from baseline (msec) \>=50%. Baseline was defined as the average of the last triplicate measurement prior to the first dosing. ECG abnormalities reported for at least 1 participant are presented here.

  Study Day 1 (baseline) up to end of study (Study Day 337).

Secondary Outcomes (36)

• Maximum Observed Serum Concentration (Cmax) of PF-06817024 Following Single Dose in Part 1

  Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, 96 hours post dose on Day 1, and on Follow-up Days 8, 15, 32, 46, 61, 91, 121, 151, 181, 211, and at Extended Follow-Up visits (up to a maximum of 780 days/18720 hours post dose).

• Cmax of PF-06817024 Following Multiple Doses in Part 1

  Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, and 96 hr post dose on Day 1, Days 8 and 15, Day 31/46 (at pre-dose, 1, 2, 4, 8, 12, 24, 48 hr), Days 61, 91, 121, 151, 181, 211, 241, at Extended Follow-Up visits (up to a maximum of 645 days/15480 hr post dose).

• Cmax of PF-06817024 in Part 2

  Pre-dose, 1, 2, 4, 8, 12, 24, and 96 hour post dose on Day 1, and Days 8, 15, 32, 61, 91, 121, 181, 211, and at Extended Follow-Up visits (up to a maximum of 690 days/16560 hours post dose).

• Cmax of PF-06817024 in Part 3

  On Day 1 (at pre-dose, 1.5, 4, and 168 hours post dose), and Days 29, 57, and 85 (at pre-dose, 1.5 and 4 hours post dose), and on Days 113, 253, 337, and Extended Follow-Up visits (up to a maximum of 882 days/21168 hours post dose on Day 85).

• Dose Normalized Maximum Observed Serum Concentration (Cmax[dn]) of PF-06817024 Following Single Dose in Part 1

  Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, 96 hours post dose on Day 1, and on Follow-up Days 8, 15, 32, 46, 61, 91, 121, 151, 181, 211, and at Extended Follow-Up visits (up to a maximum of 780 days/18720 hours post dose).

Study Arms (13)

Cohort 1

EXPERIMENTAL

10 mg of PF-06817024 or placebo

Biological: PF-06817024; Other: Placebo for PF-06817024

Cohort 2

EXPERIMENTAL

30 mg of PF-06817024 or placebo

Biological: PF-06817024; Other: Placebo for PF-06817024

Cohort 3

EXPERIMENTAL

100 mg of PF-06817024 or placebo

Biological: PF-06817024; Other: Placebo for PF-06817024

Cohort 4

EXPERIMENTAL

300 mg of PF-06817024 or placebo

Biological: PF-06817024; Other: Placebo for PF-06817024

Cohort 5

EXPERIMENTAL

1000 mg of PF-06817024 or placebo

Biological: PF-06817024; Other: Placebo for PF-06817024

Cohort 6

EXPERIMENTAL

2000 mg of PF-06817024 or placebo

Biological: PF-06817024; Other: Placebo for PF-06817024

Cohort 7

EXPERIMENTAL

30 mg subcutaneous dose of PF-06817024 or placebo

Biological: PF-06817024; Other: Placebo for PF-06817024

Cohort 8

EXPERIMENTAL

300 mg of PF-06817024 or placebo

Biological: PF-06817024; Other: Placebo for PF-06817024

Cohort 9

EXPERIMENTAL

IV dose to be determined of PF-06817024 or placebo

Biological: PF-06817024; Other: Placebo for PF-06817024

Cohort 10

EXPERIMENTAL

PF-06817024 or placebo

Biological: PF-06817024; Other: Placebo for PF-06817024

Cohort 11

EXPERIMENTAL

PF-06817024 or placebo

Biological: PF-06817024; Other: Placebo for PF-06817024

Cohort 12

EXPERIMENTAL

PF-06817024 or placebo

Biological: PF-06817024; Other: Placebo for PF-06817024

Cohort 13

EXPERIMENTAL

PF-06817024 or placebo

Biological: PF-06817024; Other: Placebo for PF-06817024

Interventions

PF-06817024 BIOLOGICAL

Subjects will be given one dose of PF-06817024 intravenously

Cohort 1; Cohort 2; Cohort 4; Cohort 5; Cohort 6; Cohort 8; Cohort 9

Placebo for PF-06817024 OTHER

Subjects will be given one dose of placebo for PF-06817024 intravenously

Cohort 1; Cohort 2; Cohort 4; Cohort 5; Cohort 6; Cohort 8; Cohort 9

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pfizer: lead

Study Sites (20)

UC Davis Dermatology

Sacramento, California, 95816, United States

Location

UC Davis CTSC Clinical Research Center

Sacramento, California, 95817, United States

Location

UC Davis Health

Sacramento, California, 95817, United States

Location

New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Location

Dermatology Physicians of Connecticut

Shelton, Connecticut, 06484, United States

Location

ForCare Clinical Research

Tampa, Florida, 33613, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46256, United States

Location

Dawes Fretzin Dermatology Group, LLC

Indianapolis, Indiana, 46256, United States

Location

The Indiana Clinical Trials Center

Plainfield, Indiana, 46168, United States

Location

Academic Dermatology

Edina, Minnesota, 55435, United States

Location

Clinical Research Institute, Inc.

Minneapolis, Minnesota, 55402, United States

Location

Ear, Nose & Throat Specialty Care of Minnesota, P.A.

Minneapolis, Minnesota, 55404, United States

Location

Prism Research, LLC

Saint Paul, Minnesota, 55114, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

Carolina Phase 1 Research, LLC

Raleigh, North Carolina, 27612, United States

Location

Vital Prospects Clinical Research Institute, PC

Tulsa, Oklahoma, 74136, United States

Location

Health Concepts

Rapid City, South Dakota, 57702, United States

Location

Lee Medical Associates, PA

San Antonio, Texas, 78213, United States

Location

Progressive Clinical Research, PA

San Antonio, Texas, 78213, United States

Location

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23502, United States

Location

Related Publications (2)

• Danto SI, Tsamandouras N, Reddy P, Gilbert SA, Mancuso JY, Page K, Beebe JS, Peeva E, Vincent MS. Exploratory pharmacodynamics and efficacy of PF-06817024 in a Phase 1 study of patients with chronic rhinosinusitis and atopic dermatitis. Allergy Asthma Clin Immunol. 2024 Aug 30;20(1):46. doi: 10.1186/s13223-024-00894-8.

  PMID: 39215351 DERIVED

• Danto SI, Tsamandouras N, Reddy P, Gilbert S, Mancuso J, Page K, Peeva E, Vincent MS, Beebe JS. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PF-06817024 in Healthy Participants, Participants with Chronic Rhinosinusitis with Nasal Polyps, and Participants with Atopic Dermatitis: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study. J Clin Pharmacol. 2024 May;64(5):529-543. doi: 10.1002/jcph.2360. Epub 2023 Oct 30.

  PMID: 37772436 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Dermatitis, Atopic; Nasal Polyps

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2016
• First Posted: April 19, 2016
• Study Start: April 27, 2016
• Primary Completion: March 9, 2021
• Study Completion: March 9, 2021
• Last Updated: May 19, 2022
• Results First Posted: May 19, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (20)