STUDY OF PF-07321332 IN HEALTHY PARTICIPANTS

NCT04756531

Last updated date
Study Location
Brussels Clinical Research Unit
Brussels, Bruxelles-capitale, Région DE, B-1070, Belgium
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Participants
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-60 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Advanced Information
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 Center1-800-718-1021[email protected]
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/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
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