Single Ascending Dose Study of Intravenous Infusion of PF 07304814 in Healthy Adult Participants

NCT04627532

Last updated date
Study Location
New Haven Clinical Research Unit
New Haven, Connecticut, 06511, United States
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]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
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

- Male and female participants must be 18 to 60 years of age. All fertile participants must agree to use a highly effective method of contraception.

- Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination.

- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

- Capable of giving signed informed consent.

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, neurological, or
allergic disease.


- History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV,
HBsAg, or HCVAb. Hepatitis B vaccination is allowed.


- Other medical or psychiatric condition including recent (within the past year) or
active suicidal ideation/behavior or laboratory abnormality that may increase the risk
of study participation.


- History of venous thromboembolic event, including deep venous thrombosis or pulmonary
embolism.


- Use of prescription or nonprescription drugs and dietary and herbal supplements within
7 days or 5 half lives (whichever is longer) prior to the first dose of study
intervention


- Previous administration with an investigational drug within 30 days (or as determined
by the local requirement) or 5 half-lives preceding the first dose of study
intervention used in this study (whichever is longer).


- A positive urine drug test at screening or admission and confirmed by repeat test, if
deemed necessary.


- Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least
5 minutes of supine rest.


- Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may
affect participant safety or interpretation of study results


- History of alcohol abuse or binge drinking and/or any other illicit drug use or
dependence within 6 months of Screening.


- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
within 60 days prior to dosing.


- Investigator site staff or Pfizer employees directly involved in the conduct of the
study, site staff otherwise supervised by the investigator, and their respective
family members

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]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

HealthySingle Ascending Dose Study of Intravenous Infusion of PF 07304814 in Healthy Adult Participants
NCT04627532
  1. New Haven, Connecticut
ALL GENDERS
18 Years+
years
MULTIPLE SITES
HealthyPharmacokinetics of Voriconazole in Obese Subjects
NCT01030653
  1. Paramus, New Jersey
ALL GENDERS
18 Years+
years
MULTIPLE SITES
HealthyA Study to Determine the Bioequivalence of Two Doses of Tafamidis
NCT04575116
  1. New Haven, Connecticut
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Single Ascending Dose Study of Intravenous Infusion of PF 07304814 in Healthy Adult Participants
Official Title  ICMJE A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO CONTROLLED, DOSE ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE ASCENDING DOSES OF PF-07304814 ADMINISTERED AS A 24-H IV INFUSION IN HEALTHY ADULT PARTICIPANTS
Brief Summary The current study is the second clinical administration with PF-07304814, the phosphate prodrug of the active moiety PF-00835231, and the first in healthy adult participants. It is to evaluate safety, tolerability and PK of single escalating doses of PF 07304814 given as a 24-h IV infusion.
Detailed Description The current study is the second clinical administration with PF-07304814, the phosphate prodrug of the active moiety PF-00835231, and the first in healthy adult participants. It is to evaluate safety, tolerability and PK of single escalating doses of PF 07304814 given as a 24-h IV infusion. This is a randomized, double-blind, sponsor-open, placebo-controlled trial. There will be 2 cohorts with a total of approximately 16 participants planned (approximately 8 participants in each cohort).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: PF-07304814
    Participants will receive PF-07304814
  • Drug: Placebo
    Participants will recieve placebo
Study Arms  ICMJE
  • Experimental: Treatment
    PF-07304814 assignment
    Intervention: Drug: PF-07304814
  • Placebo Comparator: Placebo
    Placebo assigned
    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 Completed
Actual Enrollment  ICMJE
 (submitted: November 8, 2020)
16
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 17, 2020
Actual Primary Completion Date December 17, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female participants must be 18 to 60 years of age. All fertile participants must agree to use a highly effective method of contraception.
  • Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination.
  • Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

  • Capable of giving signed informed consent.

Exclusion Criteria

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
  • History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, or HCVAb. Hepatitis B vaccination is allowed.
  • Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation.
  • History of venous thromboembolic event, including deep venous thrombosis or pulmonary embolism.
  • Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study intervention
  • Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
  • A positive urine drug test at screening or admission and confirmed by repeat test, if deemed necessary.
  • Screening supine BP ?140 mm Hg (systolic) or ?90 mm Hg (diastolic), following at least 5 minutes of supine rest.
  • Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
  • History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
  • Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
  • Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 60 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 NCT04627532
Other Study ID Numbers  ICMJE C4611007
Has Data Monitoring Committee Not Provided
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 December 2020

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