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

NCT04627532 | Completed Phase 1 FDA Drug

• 1 other identifier: C4611007
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

SAD, Healthy

Outcome Measures

Primary Outcomes (4)

• 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

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

• Number of participants with laboratory test findings of potential clinical importance

  Percentage of subjects with laboratory abnormalities

  Dosing through Day 5 of last period

• Number of participants with vital signs findings of potential clinical importance

  blood pressure, pulse rate, temperature, respiration rate

  Dosing through Day 5 of last period

• Number of participants with ECG findings of potential clinical importance

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

  Dosing through Day 5 of last period

Secondary Outcomes (12)

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

  0-48 hours post the start of dosing

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

  0-48 hours post the start of dosing

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

  0-48 hours post the start of dosing

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

  0-48 hours post the start of dosing

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

  0-48 hours post the start of dosing

Study Arms (2)

Treatment

EXPERIMENTAL

PF-07304814 assignment

Drug: PF-07304814

Placebo

PLACEBO COMPARATOR

Placebo assigned

Drug: Placebo

Interventions

PF-07304814 DRUG

Participants will receive PF-07304814

Treatment

Placebo DRUG

Participants will recieve placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Location

Related Publications (1)

• 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.

  PMID: 36285536 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

lufotrelvir

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: November 13, 2020
• Study Start: October 23, 2020
• Primary Completion: December 17, 2020
• Study Completion: December 17, 2020
• Last Updated: January 6, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)