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STUDY OF PF-07321332 IN HEALTHY PARTICIPANTS

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ClinicalTrials.gov Identifier: NCT04756531
Recruitment Status : Recruiting
First Posted : February 16, 2021
Last Update Posted : April 9, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE February 11, 2021
First Posted Date  ICMJE February 16, 2021
Last Update Posted Date April 9, 2021
Actual Study Start Date  ICMJE February 11, 2021
Estimated Primary Completion Date May 25, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2021)
  • Number of participants with Treatment Emergent Adverse Events (TEAEs) in single ascending dose (SAD) [ Time Frame: Day 1 to Day 4 ]
    An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) is defined as 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 disability/incapacity; results in congenital anomaly/birth defect. AEs include both SAEs and AEs. TEAEs are AEs that occur following the start of treatment or AEs increasing in severity during treatment
  • Number of Participants With Clinically Significant Change From Baseline in Vital Signs in SAD [ Time Frame: Day 1 to Day 4 ]
  • Number of Participants With Laboratory Abnormalities in SAD [ Time Frame: Day 1 to Day 4 ]
  • Number of Participants with Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings in SAD [ Time Frame: Day 1 to Day 4 ]
    Criteria for clinically significant changes in ECG (12-lead) are defined as: a postdose QTc interval increase by ≥30 msec from the baseline and is >450 msec; or an absolute QTc value is ≥500 msec for any scheduled ECG
  • Number of participants with TEAEs in multiple ascending dose (MAD) [ Time Frame: Day 1 to Day 12 ]
    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE is defined as 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 disability/incapacity; results in congenital anomaly/birth defect. AEs include both SAEs and AEs. TEAEs are AEs that occur following the start of treatment or AEs increasing in severity during treatment
  • Number of Participants With Clinically Significant Change From Baseline in Vital Signs in MAD [ Time Frame: Day 1 to Day 12 ]
    Vital signs evaluation includes: supine systolic and diastolic blood pressure (BP), temperature, respiratory rate and pulse rate.
  • Number of Participants With Laboratory Abnormalities in MAD [ Time Frame: Day 1 to Day 12 ]
  • Number of Participants with Clinically Significant Change From Baseline in ECGs Findings in MAD [ Time Frame: Day 1 to Day 12 ]
    Criteria for clinically significant changes in ECG (12-lead) are defined as: a postdose QTc interval increase by ≥30 msec from the baseline and is >450 msec; or an absolute QTc value is ≥500 msec for any scheduled ECG
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2021)
  • Maximum Plasma Concentration (Cmax) in SAD [ Time Frame: Day 1 to Day 4 ]
    The maximum observed plasma concentration (Cmax) is estimated based on the plasma concentrations
  • Dose Normalized Maximum Plasma Concentration (Cmax[dn]) in SAD [ Time Frame: Day 1 to Day 4 ]
    Cmax(dn) = Cmax / dose.
  • Time for Cmax (Tmax) in SAD [ Time Frame: Day 1 to Day 4 ]
    Tmax was summarized by dosing regimen. It was observed directly from data as time of first occurrence.
  • Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) in SAD [ Time Frame: Day 1 to Day 4 ]
    AUClast is summarized by dosing regimen and determined by linear/log trapezoidal method.
  • Dose Normalized Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast[dn]) in SAD [ Time Frame: Day 1 to Day 4 ]
    AUClast /dose
  • Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) in SAD [ Time Frame: Day 1 to Day 4 ]
    AUCinf = Area under the plasma concentration versus time curve (AUC) from time 0 (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
  • Dose Normalized Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf[dn]) in SAD [ Time Frame: Day 1 to Day 4 ]
    AUClast(dn) = AUClast / dose.
  • Terminal Elimination Half-Life (t½) in SAD [ Time Frame: Day 1 to Day 4 ]
    t1/2 is summarized by dosing regimen . It is determined by loge(2)/kel, where 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 is used in the regression.
  • Apparent Clearance (CL/F) in SAD [ Time Frame: Day 1 to Day 4 ]
    CL/F 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. Calculated as Dose/AUCinf. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
  • Apparent Volume of Distribution (Vz/F) in SAD [ Time Frame: Day 1 to Day 4 ]
    Vz/F 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. Vz/F is influenced by the fraction absorbed.
  • Cmax in MAD-Day 1 [ Time Frame: Day 1 Pre-dose (0 hours) to 12 hours ]
    Observed Cmax is estimated based on the plasma concentrations
  • Cmax(dn) in MAD-Day 1 [ Time Frame: Day 1 Pre-dose (0 hours) to 12 hours ]
    Cmax/dose is summarized by dosing regimen.
  • Cmax in MAD-Day 5 [ Time Frame: Day 5 Pre-dose (0 hours) to 12 hours ]
    Observed Cmax is estimated based on the plasma concentrations
  • Dose Normalized Maximum Plasma Concentration (Cmax[dn]) in MAD-Day 5 [ Time Frame: Day 5 Pre-dose (0 hours) to 12 hours ]
    Cmax/dose is summarized by dosing regimen.
  • Cmax in MAD-Day 10 [ Time Frame: Day 10 (0h) Pre-dose (0 hours) to 12 hours ]
    Observed Cmax is estimated based on the plasma concentrations
  • Dose Normalized Maximum Plasma Concentration (Cmax[dn]) in MAD-Day 10 [ Time Frame: Day 10 Pre-dose (0 hours) to 12 hours ]
    Cmax/dose is summarized by dosing regimen.
  • Time for Cmax (Tmax) in MAD-Day 1 [ Time Frame: Day 1 Pre-dose (0 hours) to 12 hours ]
    Tmax was summarized by dosing regimen. It was observed directly from data as time of first occurrence.
  • Tmax in MAD-Day 5 [ Time Frame: Day 5 Pre-dose (0 hours) to 12 hours ]
    Tmax was summarized by dosing regimen. It was observed directly from data as time of first occurrence.
  • Tmax in MAD-Day 10 [ Time Frame: Day 10 Pre-dose (0 hours) to 12 hours ]
    Tmax was summarized by dosing regimen. It was observed directly from data as time of first occurrence.
  • Area Under the Plasma Concentration-Time Profile From Time Zero To End of Dosing Interval (AUCtau) in MAD-Day 1 [ Time Frame: Day 1 Pre-dose (0 hours) to 12 hours ]
    AUCtau is summarized by dosing regimen and period. Dosing interval is the interval tau between administration of doses of drug. In this study, the dosing interval is 8 hours for three times daily (TID) dosing and 12 hours for twice daily (BID) dosing. It is determined by linear/log trapezoidal method.
  • Dose Normalized Area Under the Plasma Concentration-Time Profile From Time Zero To End of Dosing Interval (AUCtau[dn]) in MAD-Day 1 [ Time Frame: Day 1 Pre-dose (0 hours) to 12 hours ]
    AUCtau/dose is summarized by dosing regimen and period. Dosing interval is the interval tau between administration of doses of drug. In this study, the dosing interval is 8 hours for TID dosing and 12 hours for BID dosing. I
  • AUCtau in MAD-Day 5 [ Time Frame: Day 5 Pre-dose (0 hours) to 12 hours ]
    AUCtau is summarized by dosing regimen and period. Dosing interval is the interval tau between administration of doses of drug. In this study, the dosing interval is 8 hours for TID dosing and 12 hours for BID dosing. It is determined by linear/log trapezoidal method.
  • AUCtau(dn) in MAD-Day 5 [ Time Frame: Day 5 Pre-dose (0 hours) to 12 hours ]
    AUCtau/dose is summarized by dosing regimen and period. Dosing interval is the interval tau between administration of doses of drug. In this study, the dosing interval is 8 hours for TID dosing and 12 hours for BID dosing. I
  • AUCtau in MAD-Day 10 [ Time Frame: Day 10 Pre-dose (0 hours) to 12 hours ]
    AUCtau is summarized by dosing regimen and period. Dosing interval is the interval tau between administration of doses of drug. In this study, the dosing interval is 8 hours for TID dosing and 12 hours for BID dosing. It is determined by linear/log trapezoidal method.
  • Dose Normalized Area Under the Plasma Concentration-Time Profile From Time Zero To End of Dosing Interval (AUCtau[dn]) in MAD-Day 10 [ Time Frame: Day 10 Pre-dose (0 hours) to 12 hours ]
    AUCtau/dose is summarized by dosing regimen and period. Dosing interval is the interval tau between administration of doses of drug. In this study, the dosing interval is 8 hours for TID dosing and 12 hours for BID dosing. I
  • Lowest Concentration Observed During the Dosing Interval tau (Cmin) in MAD-Day 5 [ Time Frame: Day 5 Pre-dose (0 hours) to 12 hours ]
    Cmin is observed directly from data. It is summarized by dosing regimen. Dosing interval is the interval tau between administration of doses of drug. In this study, the dosing interval tau is 8 hours for TID dosing and 12 hours for BID dosing.
  • Cmin in MAD-Day 10 [ Time Frame: Day 10 Pre-dose (0 hours) to 12 hours ]
    Cmin is observed directly from data. It is summarized by dosing regimen. Dosing interval is the interval tau between administration of doses of drug. In this study, the dosing interval tau is 8 hours for TID dosing and 12 hours for BID dosing.
  • t½ in MAD-Day 10 [ Time Frame: Day 10 Pre dose (0 hours) to Day 12 (48 hours post dose) ]
    t1/2 is summarized by dosing regimen . It is determined by loge(2)/kel, where 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 is used in the regression.
  • Vz/F in MAD-Day 10 [ Time Frame: Day 10 Pre-dose (0 hours) to 12 hours ]
    Vz/F 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. VZ/F after oral dose is influenced by the fraction absorbed.
  • Peak Trough Ratio (PTR) in MAD-Day 5 [ Time Frame: Day 5 Pre-dose (0 hours) to 12 hours ]
    PTR = Cmax,ss / Cmin,ss, where ss means 'at steady state'. It is summarized by dosing regimen .
  • PTR in MAD-Day 10 [ Time Frame: Day 10 Pre-dose (0 hours) to 12 hours ]
    PTR = Cmax,ss / Cmin,ss, where ss means 'at steady state'. It is summarized by dosing regimen .
  • Observed Accumulation Ratio Based on AUC (Rac) in MAD-Day 5 [ Time Frame: Day 5 Pre-dose (0 hours) to 12 hours ]
    Rac = AUCtau,ss / AUCtau,sd, where ss means 'at steady state' and sd 'single dose'. In this study, Rac = AUCtau(Day 5) / AUCtau(Day 1). Rac is summarized by dosing regimen.
  • Rac in MAD-Day 10 [ Time Frame: Day 10 Pre-dose (0 hours) to 12 hours ]
    Rac = AUCtau,ss / AUCtau,sd, where ss means 'at steady state' and sd 'single dose'. In this study, Rac = AUCtau(Day 10) / AUCtau(Day 1). Rac is summarized by dosing regimen.
  • Observed Accumulation Ratio Based on Cmax (Rac,Cmax) in MAD-Day 5 [ Time Frame: Day 5 Pre-dose (0 hours) to 12 hours ]
    Rac,Cmax = Cmax,ss / Cmax,sd, where ss means 'at steady state' and sd 'single dose'. In this study, Rac,Cmax = Cmax(Day5) / Cmax(Day 1). Rac,Cmax is summarized by dosing regimen.
  • Rac,Cmax in MAD-Day 10 [ Time Frame: Day 10 Pre-dose (0 hours) to 12 hours ]
    Rac,Cmax = Cmax,ss / Cmax,sd, where ss means 'at steady state' and sd 'single dose'. In this study, Rac,Cmax = Cmax(Day10) / Cmax(Day 1). Rac,Cmax is summarized by dosing regimen.
  • CL/F in MAD-Day 5 [ Time Frame: Day 5 Pre-dose (0 hours) to 12 hours ]
    CL/F is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. calculated as Dose/AUC tau. Dosing interval (tau) is 8 h for TID dosing and 12 h for BID dosing.
  • CL/F in MAD-Day 10 [ Time Frame: Day 10 Pre-dose (0 hours) to 12 hours ]
    CL/F is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. calculated as Dose/AUC tau. Dosing interval (tau) is 8 h for TID dosing and 12 h for BID dosing.
  • Cumulative Amount of Drug Recovered Unchanged in Urine From Time 0 to the Dosing Interval tau Hours Post-Dose (Aetau) in MAD-Day 10 [ Time Frame: Day 10 Pre-dose (0 hours) to 12 hours ]
    Sum of (urine volume × urine concentration) for each collection over the dosing interval tau. Dosing interval (tau) is 8h for TID and 12 h for BID dosing.
  • Percentage of Dose Recovered Unchanged in Urine From Time 0 to the Dosing Interval tau Hours Post-Dose (Aetau%) in MAD-Day 10 [ Time Frame: Day 10 Pre-dose (0 hours) to 12 hours ]
    Aetau% = Aetau / Dose * 100. Aetau% is summarized by dosing regimen. Dosing interval (tau) is 8h for TID and 12 h for BID dosing.
  • Renal Clearance (Clr) in MAD-Day 10 [ Time Frame: Day 10 Pre-dose (0 hours) to 12 hours ]
    Renal clearance is calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Aetau) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau), where dosing interval is 8 hours for TID dosing and 12 hours for BID dosing.
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 STUDY OF PF-07321332 IN HEALTHY PARTICIPANTS
Official Title  ICMJE A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO CONTROLLED, SINGLE- AND MULTIPLE-DOSE ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF PF 07321332 IN HEALTHY ADULT PARTICIPANTS
Brief Summary A Phase 1, double blind, sponsor open, single and multiple ascending dose study to evaluate safety, tolerability and pharmacokinetics of PF-07321332 in healthy participants.
Detailed Description Combined 3-part study. Part-1: Single Ascending dose study. Part-2: Multiple Ascending Dose Study Part-3: Optional relative bioavailability and food effect study. Part-1 and 2 are double blind sponsor open and Part-3 is open label cross over study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Condition  ICMJE Healthy Participants
Intervention  ICMJE
  • Drug: PF-07321332 Dose 1
    PF-07321332 Dose 1
  • Drug: PF-07321332 Dose 2
    PF-07321332 Dose 2
  • Drug: PF-07321332 Dose 3
    PF-07321332 Dose 3
  • Drug: PF-07321332 Dose 4
    PF-07321332 Dose 4
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: PF-07321332 Dose 1
    Dose level 1 of PF-07321332
    Intervention: Drug: PF-07321332 Dose 1
  • Active Comparator: PF-07321332 Dose 2
    Dose level 2 of PF-07321332
    Intervention: Drug: PF-07321332 Dose 2
  • Active Comparator: PF-07321332 Dose 3
    Dose level 3 of PF-07321332
    Intervention: Drug: PF-07321332 Dose 3
  • Active Comparator: PF-07321332 Dose 4
    Dose level 4 of PF-07321332
    Intervention: Drug: PF-07321332 Dose 4
  • Placebo Comparator: Placebo
    Placebo arm
    Intervention: Drug: 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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 11, 2021)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 25, 2021
Estimated Primary Completion Date May 25, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male or female subjects between ages of 18-60 years
  • Body Mass Index (BMI) of 17.5 to 30.5kg/m2; and a total body weight >50kg (110lbs)
  • (Optional) Japanese subjects who have four Japanese biologic grandparents born in Japan

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
  • Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy, intestinal resection).
  • Positive test result for SARS-CoV-2 infection at the time of screening or Day-1.
  • Have received COVID-19 vaccine within 7 days before screening or have received only one of the 2 required doses of COVID-19 vaccine
  • Use of tobacco or nicotine containing products in excess of the equivalents of 5 cigarettes per day or 2 chews of tobacco per day
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries  ICMJE Belgium,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04756531
Other Study ID Numbers  ICMJE C4671001
2020-006073-30 ( EudraCT Number )
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 April 2021

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