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

Phase 1

Completed

Conditions: Healthy Participants

Interventions: Drug: PF-07293893
Drug: Placebo

Registration Number: NCT05907395

Lead Sponsor: Pfizer

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PF-07293893 and Placebo (Cohort 1)	Placebo	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.
PF-07293893 and Placebo (Cohort 2)	Placebo	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.
PF-07293893 and Placebo (Cohort 3)	Placebo	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.
PF-07293893 and Placebo (Cohort 2)	PF-07293893	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.
PF-07293893 and Placebo (Cohort 1)	PF-07293893	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.
PF-07293893 and Placebo (Cohort 3)	PF-07293893	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)	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.
Number of Participants With Laboratory Test Abnormalities	Day 1 of first dose up to maximum of 9 days post last dose (up to 34 days)	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.
Number of Participants With Clinically Significant Changes in Vital Signs	Day 1 of first dose up to maximum of 9 days post last dose (up to 34 days)	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.
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings	Day 1 of first dose up to maximum of 9 days post last dose (up to 34 days)	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.

Secondary Outcome Measures

Name	Time	Method
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	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	AUClast was calculated using linear/log trapezoidal method.
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
Area Under the Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUCinf) 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	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.
Terminal Half-Life (t1/2) 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	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.