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Trial record 1 of 1 for:    NCT02211261
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A Phase 1 Single/Multiple Dose Study Of PF-06293620 To Assess Safety, Tolerability And Pharmacokinetics In Subjects With Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT02211261
Recruitment Status : Completed
First Posted : August 7, 2014
Results First Posted : October 16, 2018
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE August 6, 2014
First Posted Date  ICMJE August 7, 2014
Results First Submitted Date  ICMJE January 22, 2018
Results First Posted Date  ICMJE October 16, 2018
Last Update Posted Date October 16, 2018
Actual Study Start Date  ICMJE September 15, 2014
Actual Primary Completion Date January 27, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2018)
  • Number of Participants With All-Causality and Treatment Related Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events [ Time Frame: Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit. ]
    An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of its causal relationship with study treatment. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; was life-threatening (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study drug and up to Day 85 (for SAD cohorts) or Day 169 (for MAD cohorts) that were absent before treatment or that worsened after treatment. AEs included both serious and non-serious AEs. Causality with the study treatment was determined by the investigator.
  • Number of Participants With Dose Limiting or Intolerable Adverse Events [ Time Frame: Days 1 to 85 for SAD cohorts; Days 1 to 169 for MAD Cohorts ]
    Dose limiting or intolerable AEs were originally planned to be collected. However, this outcome measure was not actually summarized, since collection and monitoring of treatment-emergent AEs was performed during the study, and deemed sufficient to ensure the participants safety.
  • Number of Participants With Positive Anti-drug Antibody (ADA) Result [ Time Frame: Days 1 to 85 for SAD cohorts; Days 1 to 169 for MAD Cohorts ]
    ADA against PF-06293620 in human serum samples was determined following a tiered approach using screening, confirmation, and titer/quantification by semi-quantitative enzyme linked immunosorbent assay (ELISA). Endpoint titer >=1.88 was considered positive.
Original Primary Outcome Measures  ICMJE
 (submitted: August 6, 2014)
  • Number and Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Between days -1 to 85 ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 85 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
  • Number and Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) related to drug treatment [ Time Frame: Between days -1 and 85 ]
    An AE was any untoward medical occurrence in a participant who received study drug with the possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment related AEs are events between first dose of study drug and up to 85 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
  • Number of participants with dose limiting or intolerable adverse events [ Time Frame: Between days -1 and 85 ]
    Dose-limiting or intolerable toxicities defined by common terminology criteria for adverse events (CTCAE) in 2 or more subjects per treatment arm
  • Incidence of immunogenicity [ Time Frame: Day -1, 15, 29 and 85 ]
    presence of anti-drug antibodies
Change History Complete list of historical versions of study NCT02211261 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2018)
  • Area Under the Serum Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06293620 (SAD Cohorts) [ Time Frame: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85 ]
    AUCinf was calculated as AUClast +(Clast*/kel), where AUClast is area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast* is the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis, kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
  • Dose-normalized AUCinf (AUCinf(dn)) of PF-06293620 (SAD Cohorts) [ Time Frame: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85 ]
    AUCinf(dn) was calculated as AUCinf/dose, where AUCinf is area under the serum concentration-time profile from time 0 extrapolated to infinite time.
  • Area Under the Serum Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06293620 (SAD Cohorts) [ Time Frame: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85 ]
    Area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast) of PF-06293620 was determined using linear/log trapezoidal method.
  • Dose-normalized AUClast (AUClast(dn)) of PF-06293620 (SAD Cohorts) [ Time Frame: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85 ]
    AUClast(dn) of PF-06293620 was calculated as AUClast/dose, where AUClast was area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration.
  • Clearance (CL) of PF-06293620 (SAD Cohorts) [ Time Frame: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85 ]
    Clearance (CL) was calculated as dose/AUCinf, where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time. This outcome measure only applies to IV arms.
  • Apparent Clearance (CL/F) of PF-06293620 (SAD Cohorts) [ Time Frame: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85 ]
    Apparent Clearance (CL/F) of PF-06293620 was calculated as dose/AUCinf, where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time. This outcome measure only applies to SC arms.
  • Maximum Serum Concentration (Cmax) of PF-06293620 (SAD Cohorts) [ Time Frame: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85 ]
    Maximum serum concentration (Cmax) of PF-06293620 was observed directly from data.
  • Time for Maximum Serum Concentration (Tmax) of PF-06293620 (SAD Cohorts) [ Time Frame: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85 ]
    Time for Maximum serum concentration (Tmax) of PF-06293620 was observed directly from data as time of first occurrence.
  • Steady-state Volume of Distribution (Vss) of PF-06293620 (SAD Cohorts) [ Time Frame: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85 ]
    Steady-state volume of distribution (Vss) of PF-06293620 was calculated as CL*MRT, where MRT was the mean residence time calculated as (AUMCinf/AUCinf - infusion duration/2), AUMCinf was area under the moment curve from time 0 extrapolated to infinity; CL was the clearance. This outcome measure only applies to IV arms.
  • Apparent Volume of Distribution (Vz/F) of PF-06293620 (SAD Cohorts) [ Time Frame: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85 ]
    Apparent Volume of Distribution (Vz/F) of PF-06293620 was calculated as dose/(AUCinf*kel), where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time, kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. This outcome measure only applies to SC arms.
  • Terminal Elimination Half-life (Thalf) of PF-06293620 (SAD Cohorts) [ Time Frame: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85 ]
    Terminal elimination half-life (Thalf) of PF-06293620 was calculated as ln(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
  • Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration [ Time Frame: Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169 ]
    Tau refers to the dosing interval, which was 4 weeks (672 hours). Area under the concentration-time profile from time 0 to time tau (AUCtau) was determined using linear/log trapezoidal method.
  • Maximum Serum Concentration (Cmax) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration [ Time Frame: Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169 ]
  • Average Concentration (Cav) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration [ Time Frame: Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169 ]
    Average Concentration (Cav) of PF-06293620 was calculated as AUCtau/tau, where AUCtau was area under the concentration-time profile from time 0 to time tau, and tau was the dosing interval, 4 weeks (672 hours).
  • Lowest Concentration Observed During the Dosing Interval (Cmin) of PF-06293620 (MAD Cohorts) After Day 57 Administration [ Time Frame: Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169 ]
  • Time for Maximum Serum Concentration (Tmax) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration [ Time Frame: Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169 ]
    Time for maximum serum concentration (Tmax) of PF-06293620 was observed directly from data as time of first occurrence.
  • Apparent Clearance (CL/F) of PF-06293620 (MAD Cohorts) After Day 57 Administration [ Time Frame: Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169 ]
    Apparent clearance (CL/F) of PF-06293620 was calculated as dose/AUCtau, where AUCtau was area under the concentration-time profile from time 0 to time tau, and tau was the dosing interval, 4 weeks (672 hours).
  • Apparent Volume of Distribution (Vz/F) of PF-06293620 (MAD Cohorts) After Day 57 Administration [ Time Frame: Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169 ]
    Apparent volume of distribution (Vz/F) of PF-06293620 was calculated as dose/(AUCtau/kel), where AUCtau was area under the concentration-time profile from time 0 to time tau, and tau was the dosing interval, 4 weeks (672 hours); and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
  • Terminal Elimination Half-life (Thalf) of PF-06293620 (MAD Cohorts) After Day 57 Administration [ Time Frame: Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169 ]
    Terminal elimination half-life (Thalf) of PF-06293620 was calculated as ln(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
  • Observed Accumulation Ratio Based on AUC (Rac) of PF-06293620 (MAD Cohorts) [ Time Frame: Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169 ]
    Observed accumulation ratio based on AUC (Rac) of PF-06293620 was calculated as AUCtau(Day57)/AUCtau(Day1).
  • Observed Accumulation Ratio Based on Cmax (Rac,Cmax) of PF-06293620 (MAD Cohorts) [ Time Frame: Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169 ]
    Observed accumulation ratio based on Cmax (Rac,Cmax) of PF-06293620 was calculated as Cmax(Day57)/Cmax(Day1).
Original Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2014)
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: Days 1-15,22,29,43,57,85 ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 85)] [ Time Frame: Days 1-15,22,29,43,57,85 ]
    AUC (0 - 85)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 85). It is obtained from AUC (0 - t) plus AUC (t - 8).
  • Systemic Clearance (CL) [ Time Frame: Days 1-15,22,29,43,57,85 ]
    CL is a quantitative measure of the rate at which a drug substance is removed from the body.
  • Apparent Oral Clearance (CL/F) [ Time Frame: Days 1-15,22,29,43,57,85 ]
    Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Days 1-15,22,29,43,57,85 ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Days 1-15,22,29,43,57,85 ]
  • Apparent Volume of Distribution (Vz/F) [ Time Frame: Days 1-15,22,29,43,57,85 ]
    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
  • Plasma Decay Half-Life (t1/2) [ Time Frame: Days 1-15,22,29,43,57,85 ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 1 Single/Multiple Dose Study Of PF-06293620 To Assess Safety, Tolerability And Pharmacokinetics In Subjects With Type 2 Diabetes Mellitus
Official Title  ICMJE A Phase 1 Double-blind, Placebo-controlled, Randomized, Single- And Multiple-ascending Dose Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Pf-06293620 In Subjects With Type 2 Diabetes Mellitus
Brief Summary A first in human study to determine the safety, tolerability and pharmacokinetics of single and multiple ascending doses of PF-06293620 in subjects with Type 2 Diabetes Mellitus
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Biological: PF-06293620
    subcutaneous, single dose 0.3 mg/kg
  • Biological: Placebo
    Subcutaneous normal saline single dose
  • Biological: PF-06293620
    Subcutaneous, single dose 1.0 mg/kg
  • Biological: PF-06293620
    Subcutaneous single dose 3 mg/kg
  • Biological: PF-06293620
    Subcutaneous single dose 6 mg/kg
  • Biological: PF-06293620
    Intravenous infusion single dose 1 mg/kg
  • Biological: Placebo
    Intravenous infusion normal saline single dose
  • Biological: PF-06293620
    Subcutaneous injection multiple dose 75 mg (Days 1, 29 and 57)
  • Biological: Placebo
    Subcutaneous injection normal saline multiple dose (Days 1, 29 and 57)
  • Biological: PF-06293620
    Subcutaneous injection multiple dose 150 mg (Days 1, 29 and 57)
  • Biological: PF-06293620
    Subcutaneous injection multiple dose 250 mg (Days 1, 29 and 57)
  • Biological: PF-06293620
    Subcutaneous injection multiple dose TBD mg (Days TBD)
  • Biological: Placebo
    Subcutaneous injection normal saline multiple dose (Days TBD)
Study Arms  ICMJE
  • Experimental: Cohort 1-PF-06293620 or placebo
    Single Ascending Dose PF-06293620 or placebo
    Interventions:
    • Biological: PF-06293620
    • Biological: Placebo
  • Experimental: Cohort 2-PF-06293620 or placebo
    Single Ascending Dose PF-06293620 or placebo
    Interventions:
    • Biological: PF-06293620
    • Biological: Placebo
  • Experimental: Cohort 3-PF-06293620 or placebo
    Single Ascending Dose PF-06293620 or placebo
    Interventions:
    • Biological: PF-06293620
    • Biological: Placebo
  • Experimental: Cohort 4-PF-06293620 or placebo
    Single Ascending Dose PF-06293620 or placebo
    Interventions:
    • Biological: PF-06293620
    • Biological: Placebo
  • Experimental: Cohort 5-PF-06293620 or placebo
    Single Ascending Dose PF-06293620 or placebo
    Interventions:
    • Biological: PF-06293620
    • Biological: Placebo
  • Experimental: Cohort 6-PF-06293620 or placebo
    Multiple Ascending Dose PF-06293620 or placebo
    Interventions:
    • Biological: PF-06293620
    • Biological: Placebo
  • Experimental: Cohort 7 PF-06293620 or placebo
    Multiple Ascending Dose PF-06293620 or placebo
    Interventions:
    • Biological: PF-06293620
    • Biological: Placebo
  • Experimental: Cohort 8-PF-06293620 or placebo
    Multiple Ascending Dose PF-06293620 or placebo
    Interventions:
    • Biological: PF-06293620
    • Biological: Placebo
  • Experimental: Cohort 9-PF-06293620 or placebo
    Multiple Ascending Dose PF-06293620 or placebo
    Interventions:
    • Biological: PF-06293620
    • Biological: Placebo
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 Completed
Actual Enrollment  ICMJE
 (submitted: May 8, 2017)
84
Original Estimated Enrollment  ICMJE
 (submitted: August 6, 2014)
48
Actual Study Completion Date  ICMJE January 27, 2017
Actual Primary Completion Date January 27, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men and women of non-childbearing potential with Type 2 Diabetes Mellitus
  • Subjects on stable doses of metformin >/= 1500 mg daily (SAD cohorts) or >/= 1000 mg daily (MAD cohorts) x 30 days prior to screening
  • HbA1c 7-10% (SAD Cohorts) or 6.5-10% (MAD cohorts) inclusive at screening
  • Fasting C-peptide >1.12 ng/mL (SAD cohorts) or >/= 0.8 mg/mL (MAD cohorts) at screening

Exclusion Criteria:

  • History of Type 1 diabetes mellitus
  • Evidence of diabetic complications with significant end-organ damage
  • History of chronic pancreatitis or at high risk for pancreatitis
  • Poorly controlled hypertension
  • History of cardiovascular or cerebrovascular event or procedure
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT02211261
Other Study ID Numbers  ICMJE B3501001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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 October 2018

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