Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04627532
Recruitment Status : Completed
First Posted : November 13, 2020
Last Update Posted : January 6, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: PF-07304814 Drug: Placebo Phase 1

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: 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
Actual Study Start Date : October 23, 2020
Actual Primary Completion Date : December 17, 2020
Actual Study Completion Date : December 17, 2020

Arm Intervention/treatment
Experimental: Treatment
PF-07304814 assignment
Drug: PF-07304814
Participants will receive PF-07304814

Placebo Comparator: Placebo
Placebo assigned
Drug: Placebo
Participants will recieve placebo




Primary Outcome Measures :
  1. Number of participants with treatment emergent treatment-related adverse event(s) [ Time Frame: Dosing through follow-up call (28-32 days after last dose of investigational product) ]
    Frequency, severity and causal relationship of treatment emergent adverse events (TEAEs) and withdrawals due to TEAEs

  2. Number of participants with laboratory test findings of potential clinical importance [ Time Frame: Dosing through Day 5 of last period ]
    Percentage of subjects with laboratory abnormalities

  3. Number of participants with vital signs findings of potential clinical importance [ Time Frame: Dosing through Day 5 of last period ]
    blood pressure, pulse rate, temperature, respiration rate

  4. Number of participants with ECG findings of potential clinical importance [ Time Frame: Dosing through Day 5 of last period ]
    Number of subjects with change from baseline in electrocardiogram (ECG) parameters


Secondary Outcome Measures :
  1. Plasma Cmax of PF-07304814 (prodrug) and PF 00835231 (active moiety) [ Time Frame: 0-48 hours post the start of dosing ]
    Maximum plasma concentration

  2. Plasma C24 of PF-07304814 (prodrug) and PF 00835231 (active moiety) [ Time Frame: 0-48 hours post the start of dosing ]
    Plasma concentration at the end of infusion (24 hours post the start of infusion)

  3. Plasma Css of PF-07304814 (prodrug) and PF 00835231 (active moiety) [ Time Frame: 0-48 hours post the start of dosing ]
    Plasma steady state concertation

  4. Plasma AUClast of PF-07304814 (prodrug) and PF 00835231 (active moiety) [ Time Frame: 0-48 hours post the start of dosing ]
    Area under the serum concentration time profile from time zero to the time of the last quantifiable concentration.

  5. Plasma AUCinf of PF-07304814 (prodrug) and PF 00835231 (active moiety) [ Time Frame: 0-48 hours post the start of dosing ]
    Area under the serum concentration time profile from time zero to infinity.

  6. Plasma AUCinf (dn) of PF-07304814 (prodrug) and PF 00835231 (active moiety) [ Time Frame: 0-48 hours post the start of dosing ]
    Dose normalized AUCinf

  7. Plasma Css (dn) of PF-07304814 (prodrug) and PF 00835231 (active moiety) [ Time Frame: 0-48 hours post the start of dosing ]
    Dose normalized Css

  8. Plasma t1/2 of PF-07304814 (prodrug) and PF 00835231 (active moiety) [ Time Frame: 0-48 hours post the start of dosing ]
    Terminal half life

  9. Plasma CL of PF-07304814 (prodrug) [ Time Frame: 0-48 hours post the start of dosing ]
    Clearance

  10. Plasma Vdss of PF-07304814 (prodrug) [ Time Frame: 0-48 hours post the start of dosing ]
    Volume of distribution at steady state

  11. PF-00835231 urinary PK: Ae [ Time Frame: 0-36 hours post the start of dosing ]
    Amount of unchanged drug excreted in urine over collection interval

  12. PF-00835231 urinary PK: Ae% [ Time Frame: 0-36 hours post the start of dosing ]
    Percent of dose excreted in urine as unchanged drug over the collection interval.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04627532


Locations
Layout table for location information
United States, Connecticut
New Haven Clinical Research Unit
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04627532    
Other Study ID Numbers: C4611007
First Posted: November 13, 2020    Key Record Dates
Last Update Posted: January 6, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
SAD, Healthy