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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: PF-07293893
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-07293893 and Placebo (Cohort 1)<br>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<br>* PF-07293893 will be prepared as an oral suspension given in escalating single doses to be determined.<br>Drug: Placebo<br>* Matching placebo will be prepared as an oral suspension given in each cohort.<br>|
| Experimental: PF-07293893 and Placebo (Cohort 2)<br>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<br>* PF-07293893 will be prepared as an oral suspension given in escalating single doses to be determined.<br>Drug: Placebo<br>* Matching placebo will be prepared as an oral suspension given in each cohort.<br>|
| Experimental: PF-07293893 and Placebo (Cohort 3)<br>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<br>* PF-07293893 will be prepared as an oral suspension given in escalating single doses to be determined.<br>Drug: Placebo<br>* Matching placebo will be prepared as an oral suspension given in each cohort.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) |  | Baseline up to 35 days after last dose of study intervention (approximately 11 weeks) | 
| Number of Participants With Clinical Laboratory Abnormalities |  | Baseline up to 10 days after last dose of study intervention (approximately 5 weeks) | 
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs |  | Baseline up to 10 days after last dose of study intervention (approximately 5 weeks) | 
| Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings |  | Baseline up to 10 days after last dose of study intervention (approximately 5 weeks) | 
| Number of Participants With Clinically Significant Change From Baseline in Neurological Examination Findings |  | Baseline up to 10 days after last dose of study intervention (approximately 5 weeks) | 
| Number of Participants With Clinically Significant Change From Baseline in Telemetry Findings |  | 0 to 8 hours post-dose on Day 1 in each period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) of PF-07293893 |  | Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 36, 48, and 72 post-dose in each period | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07293893 |  | Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 36, 48, and 72 post-dose in each period | 
| Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) of PF-07293893 |  | Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 36, 48, and 72 post-dose in each period | 
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07293893 |  | Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 36, 48, and 72 post-dose in each period | 
| Plasma Half-Life (t1/2) of PF-07293893 |  | Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 36, 48, and 72 post-dose in each period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PF-07293893, Single ascending dose, Tolerability, Pharmacokinetics, Safety