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Trial record 1 of 1 for:    NCT02871037
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Single Dose, Repeated Dose, and Conditional Food Effect Study of PF-05221304 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02871037
Recruitment Status : Completed
First Posted : August 18, 2016
Last Update Posted : May 24, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE August 10, 2016
First Posted Date  ICMJE August 18, 2016
Last Update Posted Date May 24, 2018
Actual Study Start Date  ICMJE August 2016
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2016)
  • Part 1: Number of Subjects experiencing an Adverse Event [ Time Frame: Screening up to 28 days after last dose of study medication ]
    Assessment by adverse event monitoring, 12 lead ECGs, telemetry, vital signs and clinical safety laboratory measurements. Treatment-related AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. 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; 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 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Drug was assessed by the investigator (Yes/No). Subjects with multiple occurrences of an AE within a category were counted once within the category.
  • Part 2: Number of Subjects experiencing an Adverse Event [ Time Frame: Screening up to 28 days after last dose of study medication ]
    Assessment by adverse event monitoring, 12 lead ECGs, telemetry, vital signs and clinical safety laboratory measurements. Treatment-related AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. 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; 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 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Drug was assessed by the investigator (Yes/No). Subjects with multiple occurrences of an AE within a category were counted once within the category.
  • Part 3: Maximum Observed Plasma Concentration (Cmax) for PF-05221304 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose ]
    Maximum Observed Plasma Concentration (Cmax)
  • Part 3: Time to Reach Maximum Observed Concentration for PF-05221304 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose ]
    Time to Reach Maximum Observed Plasma Concentration (Tmax)
  • Part 3: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05221304 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
  • Part 3: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for PF-05221304 (as permitted) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose ]
    AUC (0-infinity)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-infinity). It is obtained from AUC (0-t) plus AUC (t-infinity).
  • Part 3: Plasma Decay Half-Life (t1/2) for PF-05221304 (as permitted) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose ]
    Plasma Decay Half-Life (t1/2)
  • Part 3: Apparent Total Body Clearance (CL/F) for PF-05221304 (as permitted) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose ]
    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 apparent total body 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.
  • Part 3: Apparent Volume of Distribution (Vz/F) for PF-05221304 (as permitted) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2016)
  • Part 1:Maximum Observed Plasma Concentration (Cmax) for PF-05221304 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose ]
    Maximum Observed Plasma Concentration (Cmax)
  • Part 1: Time to Reach Maximum Observed Concentration for PF-05221304 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose ]
    Time to Reach Maximum Observed Plasma Concentration (Tmax)
  • Part 1: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05221304 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
  • Part 1: dose-normalized Cmax and AUClast for PF05221304 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose ]
  • Part 1: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for PF-05221304 (as permitted) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose ]
    AUC (0-infinity)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-infinity). It is obtained from AUC (0-t) plus AUC (t-infinity).
  • Part 1: Plasma Decay Half-Life (t1/2) for PF-05221304 (as permitted) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose ]
    Plasma Decay Half-Life (t1/2)
  • Part 1: Apparent Total Body Clearance (CL/F) for PF-05221304 (as permitted) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose ]
    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 apparent total body 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.
  • Part 1: Apparent Volume of Distribution (Vz/F) for PF-05221304 (as permitted) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose ]
    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.
  • Part 2: Single dose plasma parameters of Cmax for PF-05221304 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose on Day 1 ]
    Maximum Observed Plasma Concentration (Cmax)
  • Part 2: Single-dose plasma parameters of Tmax for PF-05221304 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose on Day 1 ]
    Time to Reach Maximum Observed Plasma Concentration (Tmax)
  • Part 2: Single-dose plasma parameters of Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for PF-05221304 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose on Day 1 ]
    Area under the concentration curve from time 0 to end of dosing interval (AUCtau)
  • Part 2: Multiple-dose plasma parameters of Cmax for PF-05221304 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose for Day 7; (and Day 14, as permitted) ]
    Maximum Observed Plasma Concentration (Cmax)
  • Part 2: Multiple-dose plasma parameters of Tmax for PF-05221304 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose for Day 7; (and Day 14, as permitted) ]
    Time to Reach Maximum Observed Plasma Concentration (Tmax)
  • Part 2: Multiple-dose plasma parameters of AUCtau for PF-05221304 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose for Day 7; (and Day 14, as permitted) ]
    Area under the concentration curve from time 0 to end of dosing interval (AUCtau)
  • Part 2: Multiple-dose plasma parameters of Minimum Observed Plasma Trough Concentration (Cmin) for PF-05221304 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose for Day 7; (and Day 14, as permitted) ]
  • Part 2: Multiple-dose plasma parameters of CL/F for PF-05221304 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose for Day 7; (and Day 14, as permitted) ]
    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 apparent total body 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.
  • Part 2: Multiple-dose plasma parameters of Vz/F for PF-05221304 (as permitted) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours on Day 1 and 7, and 0 hr on Day 2, Day 4, Day 8, Day 10, Day 13, Day 15, and Day 16 post dose ]
    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.
  • Part 2: Multiple-dose plasma parameters of Peak-trough ratio (PTR) for PF-05221304 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose for Day 7; (and Day 14, as permitted) ]
  • Part 2: Multiple-dose plasma parameters of Observed accumulation ratio for Cmax (Rac(Cmax)) for PF-05221304 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose for Day 7; (and Day 14, as permitted) ]
  • Part 2: Multiple-dose plasma parameters of Observed accumulation ratio (Rac(AUCtau)) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose for Day 7; (and Day 14, as permitted) ]
  • Part 2: Multiple-dose plasma parameters of Plasma Decay Half-Life (t1/2) for PF-05221304 (as permitted) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours on Day 1 and 7, and 0 hr on Day 2, Day 4, Day 8, Day 10, Day 13, Day 15, and Day 16 post dose ]
    Plasma Decay Half-Life (t1/2)
  • Part 3: Number of Subjects experiencing an Adverse Event [ Time Frame: Screening up to 28 days after last dose of study medication ]
    Assessment by adverse event monitoring, 12 lead ECGs, telemetry, vital signs and clinical safety laboratory measurements. Treatment-related AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. 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; 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 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Drug was assessed by the investigator (Yes/No). Subjects with multiple occurrences of an AE within a category were counted once within the category.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single Dose, Repeated Dose, and Conditional Food Effect Study of PF-05221304 in Healthy Subjects
Official Title  ICMJE A Phase 1, 3-part Study Of Pf-05221304 In Healthy Adults: Part 1 - Randomized, Double-blind, Placebo-controlled Assessment Of Safety And Pharmacokinetics Of Single, Escalating, Oral Doses; Part 2 - Randomized, Double-blind, Placebo-controlled Assessment Of Safety And Pharmacokinetics Of Repeated, Escalating, Oral Doses; Conditional Part 3 - Effect Of Food On The Pharmacokinetics Of Pf-05221304
Brief Summary The current study is the first clinical trial proposed with PF-05221304. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of single and repeated doses of PF-05221304 to healthy adult subjects. The study may also evaluate effect of food on PK of PF-05221304.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Normal Healthy
Intervention  ICMJE
  • Drug: PF-05221304
    Single or repeated, escalating dose of PF-05221304
  • Other: Placebo
    single or repeated dose of placebo
Study Arms  ICMJE
  • Experimental: Part 1_Cohort 1_Active
    Single, escalating dose of PF-05221304
    Intervention: Drug: PF-05221304
  • Placebo Comparator: Part 1_Cohort 1_Placebo
    Single dose of Placebo
    Intervention: Other: Placebo
  • Experimental: Part 1_Cohort 2_Active
    Single, escalating dose of PF-05221304
    Intervention: Drug: PF-05221304
  • Experimental: Part 1_Cohort 2_Placebo
    Single dose of Placebo
    Intervention: Other: Placebo
  • Experimental: Part 2_Active
    Repeated, escalating doses of PF-05221304
    Intervention: Drug: PF-05221304
  • Placebo Comparator: Part 2_Placebo
    Repeated doses of placebo
    Intervention: Other: Placebo
  • Experimental: Part 3
    Single dose of PF-05221304 with and without food
    Intervention: Drug: PF-05221304
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: April 6, 2017)
96
Original Estimated Enrollment  ICMJE
 (submitted: August 12, 2016)
98
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy males and female of non-childbearing potential;
  • Body Mass Index 17.5-30.5 kg/m2;
  • Body weight >50 kg;

Exclusion Criteria:

  • Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergises, but excluding untreated, asymptomatic, seasonal allergies at time of dosing
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (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 NCT02871037
Other Study ID Numbers  ICMJE C1171001
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 May 2018

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