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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: PF-07293893; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05907395

C5171001

2023-504921-37-00 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 3 patient groups

PF-07293893 and Placebo (Cohort 1)

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: PF-07293893

PF-07293893 and Placebo (Cohort 2)

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: PF-07293893

PF-07293893 and Placebo (Cohort 3)

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: PF-07293893