A Study to Learn About the Study Medicine (PF-07293893) at Different Dose Levels in Healthy Adults

A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, 4-PERIOD, CROSSOVER, FIRST-IN-HUMAN STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE ASCENDING ORAL DOSES OF PF-07293893 ADMINISTERED TO HEALTHY ADULT PARTICIPANTS

The purposes of the study are:

To learn about the safety and tolerability of study medicine (PF-07293893). Tolerability is the extent to which side effects can be tolerated. Side effects are unwanted reactions to the study medicine.

To measure the amount of PF-07293893 in blood after the medicine is taken by mouth.

The study is seeking participants who:

• Are females of non-childbearing potential and males 18 to 65 years of age
• Are in generally healthy condition
• Have not had viral infections (HIV, HBV or HCV). HIV, human immunodeficiency virus. HBV, human hepatitis B virus. HCV, human hepatitis C virus.

Participants will receive either PF-07293893 or placebo (dummy pill) by chance. Participants will undergo up to 4 treatments periods in this study. Everyone will receive up to 4 doses of study medicine and up to 2 doses of placebo. In each period, participants will stay in study clinic for 5 days. There will be at least 2 days between each treatment period.

Participants will be involved in this study for about 14 weeks. During their stay, participants will undergo several examinations. Participants will also have their blood collected by the study doctors for several times.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: PF-07293893; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles-capitale, Région DE
    • Brussels, Bruxelles-capitale, Région DE, Belgium, B-1070
      • Pfizer Clinical Research Unit - Brussels

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

This study is seeking participants who are:

• Females of non-childbearing potential and males 18 to 65 years of age, inclusive, at the time of signing the informed consent document (ICD) who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.

This study is not seeking participants who have:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
• History of human immunodeficiency virus infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen, or hepatitis C antibody. Hepatitis B vaccination is allowed.
• Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions or situations related to coronavirus disease 2019 (COVID-19) pandemic that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
• Screening supine blood pressure (BP) ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic) for participants <60 years; and ≥150/90 mm/Hg for participants ≥60 years old, following at least 5 minutes of supine rest.
• Renal impairment as defined by an estimated glomerular filtration rate (eGFR) <75 mL/min/1.73m².
• Standard 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
• Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:

Alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin ≥1.05 × upper limit of normal (ULN), participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PF-07293893 and Placebo (Cohort 1); Single dose administration of PF-07293893 and placebo; Within a cohort, participants will receive up to 4 doses of PF-07293893 and up to 2 doses of placebo.	Drug: PF-07293893; PF-07293893 will be prepared as an oral suspension given in escalating single doses to be determined.; Drug: Placebo; Matching placebo will be prepared as an oral suspension given in each cohort.
Experimental: PF-07293893 and Placebo (Cohort 2); Single dose administration of PF-07293893 and placebo; Within a cohort, participants will receive up to 4 doses of PF-07293893 and up to 2 doses of placebo.	Drug: PF-07293893; PF-07293893 will be prepared as an oral suspension given in escalating single doses to be determined.; Drug: Placebo; Matching placebo will be prepared as an oral suspension given in each cohort.
Experimental: PF-07293893 and Placebo (Cohort 3); Single dose administration of PF-07293893 and placebo; Within a cohort, participants will receive up to 4 doses of PF-07293893 and up to 2 doses of placebo.	Drug: PF-07293893; PF-07293893 will be prepared as an oral suspension given in escalating single doses to be determined.; Drug: Placebo; Matching placebo will be prepared as an oral suspension given in each cohort.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	An Adverse event (AE) was any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were events with onset dates on or after the start of the study drug.	Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
Number of Participants With Laboratory Test Abnormalities	Following parameters were analyzed for laboratory abnormalities: hematology (lymphocytes <0.8*lower limit of normal [LLN], lymphocytes/leukocytes <0.8*LLN, neutrophils <0.8*LLN, neutrophils/leukocytes <0.8*LLN, eosinophils/leukocytes >1.2*upper limit of normal [ULN], monocytes >1.2*ULN, monocytes/leukocytes >1.2*ULN); clinical chemistry (aspartate aminotransferase >3.0*ULN, potassium >1.1*ULN, creatine kinase >2.0*ULN); urinalysis (urine specific gravity <1.003 ,>1.030, ketones >=1, urine hemoglobin >=1, urobilinogen >=1, urine bilirubin >=1, leukocyte esterase >=1). In this outcome measure, participants with any laboratory abnormalities are reported.	Day 1 of first dose up to maximum of 9 days post last dose (up to 34 days)
Number of Participants With Clinically Significant Changes in Vital Signs	Vital signs assessments included blood pressure, pulse rate, respiratory rate and body temperature. Clinical significance of vital signs was determined based by investigator's discretion.	Day 1 of first dose up to maximum of 9 days post last dose (up to 34 days)
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings	ECG parameters included heart rate, PR interval, QTc corrected using Fridericia's formula (QTcF) and QRS complex. Clinically significant ECG findings were determined by the investigator's discretion.	Day 1 of first dose up to maximum of 9 days post last dose (up to 34 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Plasma Concentration (Cmax) of PF-07293893		Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 48 and 72 hours post dose of any treatment period
Time for Cmax (Tmax) of PF-07293893		Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 48 and 72 hours post dose of any treatment period
Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PF-07293893	AUClast was calculated using linear/log trapezoidal method.	Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 48 and 72 hours post dose of any treatment period
Area Under the Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07293893	AUCinf was calculated as AUClast + (Clast*/kel), where Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis, and kel is the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve.	Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 48 and 72 hours post dose of any treatment period
Terminal Half-Life (t1/2) of PF-07293893	t1/2 was calculated as log^e (2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve.	Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 48 and 72 hours post dose of any treatment period

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2023
• Primary Completion (Actual): March 22, 2024
• Study Completion (Actual): March 22, 2024

Study Registration Dates

• First Submitted: June 8, 2023
• First Submitted That Met QC Criteria: June 8, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: March 21, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Safety; Pharmacokinetics; Tolerability; Single ascending dose; PF-07293893
• Other Study ID Numbers: C5171001; 2023-504921-37-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes