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HealthyPhase 1NCT04627532

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

A Phase 1 study testing PF-07304814 in people with Healthy, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
PF-07304814
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
16 participants
Where
1 siteUnited States
Study dates
23 Oct 2020to 17 Dec 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • New Haven Clinical Research Unit

    New Haven, Connecticut, 06511

Other trials in United States

About this study

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

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.

Read the 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).

Conditions
Healthy
Being tested
PF-07304814, Placebo
Keywords
SAD, Healthy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-07304814Drug

    Participants will receive PF-07304814

  • PlaceboDrug

    Participants will recieve placebo

Study groups in NCT04627532
Study groupRoleWhat they receive
TreatmentExperimentalPF-07304814 assignment
Receives: Drug: PF-07304814
PlaceboPlacebo comparatorPlacebo assigned
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with treatment emergent treatment-related adverse event(s)

    Frequency, severity and causal relationship of treatment emergent adverse events (TEAEs) and withdrawals due to TEAEs

    Measured: Dosing through follow-up call (28-32 days after last dose of investigational product)

  2. Number of participants with laboratory test findings of potential clinical importance

    Percentage of subjects with laboratory abnormalities

    Measured: Dosing through Day 5 of last period

  3. Number of participants with vital signs findings of potential clinical importance

    blood pressure, pulse rate, temperature, respiration rate

    Measured: Dosing through Day 5 of last period

  4. Number of participants with ECG findings of potential clinical importance

    Number of subjects with change from baseline in electrocardiogram (ECG) parameters

    Measured: Dosing through Day 5 of last period

Secondary outcomes (12)

  1. Plasma Cmax of PF-07304814 (prodrug) and PF 00835231 (active moiety)

    Maximum plasma concentration

    Measured: 0-48 hours post the start of dosing

  2. Plasma C24 of PF-07304814 (prodrug) and PF 00835231 (active moiety)

    Plasma concentration at the end of infusion (24 hours post the start of infusion)

    Measured: 0-48 hours post the start of dosing

  3. Plasma Css of PF-07304814 (prodrug) and PF 00835231 (active moiety)

    Plasma steady state concertation

    Measured: 0-48 hours post the start of dosing

  4. Plasma AUClast of PF-07304814 (prodrug) and PF 00835231 (active moiety)

    Area under the serum concentration time profile from time zero to the time of the last quantifiable concentration.

    Measured: 0-48 hours post the start of dosing

  5. Plasma AUCinf of PF-07304814 (prodrug) and PF 00835231 (active moiety)

    Area under the serum concentration time profile from time zero to infinity.

    Measured: 0-48 hours post the start of dosing

  6. Plasma AUCinf (dn) of PF-07304814 (prodrug) and PF 00835231 (active moiety)

    Dose normalized AUCinf

    Measured: 0-48 hours post the start of dosing

  7. Plasma Css (dn) of PF-07304814 (prodrug) and PF 00835231 (active moiety)

    Dose normalized Css

    Measured: 0-48 hours post the start of dosing

  8. Plasma t1/2 of PF-07304814 (prodrug) and PF 00835231 (active moiety)

    Terminal half life

    Measured: 0-48 hours post the start of dosing

  9. Plasma CL of PF-07304814 (prodrug)

    Clearance

    Measured: 0-48 hours post the start of dosing

  10. Plasma Vdss of PF-07304814 (prodrug)

    Volume of distribution at steady state

    Measured: 0-48 hours post the start of dosing

  11. PF-00835231 urinary PK: Ae

    Amount of unchanged drug excreted in urine over collection interval

    Measured: 0-36 hours post the start of dosing

  12. PF-00835231 urinary PK: Ae%

    Percent of dose excreted in urine as unchanged drug over the collection interval.

    Measured: 0-36 hours post the start of dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2020
  2. Study start23 Oct 2020
  3. Primary completion17 Dec 2020
  4. Study completion17 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04627532
Sponsor's protocol ID
C4611007
Status last verified
Dec 2020
First submitted
21 Oct 2020
Last updated
6 Jan 2021
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • Zhu T, Pawlak S, Toussi SS, Hackman F, Thompson K, Song W, Salageanu J, Winter E, Shi H, Winton J, Binks M. Safety, Tolerability, and Pharmacokinetics of Intravenous Doses of PF-07304814, a Phosphate Prodrug Protease Inhibitor for the Treatment of SARS-CoV-2, in Healthy Adult Participants. Clin Pharmacol Drug Dev. 2022 Dec;11(12):1382-1393. doi: 10.1002/cpdd.1174. Epub 2022 Oct 26.

    PubMed 36285536

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-07304814 in people with Healthy, run by Pfizer at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04627532, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2021.

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