The purpose of this clinical study is to learn about the safety and effects of the study medicine (PF-07054894) in healthy Japanese participants. The study is seeking the following participants: * Male or female Japanese participants aged 18 years or older. The participants should be healthy after going through some medical tests. * Have a Body Mass Index (BMI) of 16 to 32 kilogram per meter squared; and a total body weight of more than 45 kilograms (100 pounds). * Are willing and able to follow all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. In research, the participants in clinical studies are assigned by chance to separate groups that are given different treatments. Hence participants will be by chance assigned to receive either PF-07054894 or a harmless treatment that has no medical effect (placebo). Both these will be taken by mouth for 14 days. The total duration of the study is about 11 weeks, with a follow-up via telephone about 6 weeks after first treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
6
multiple oral doses of PF-07054894 for 14 days
Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, Belgium
Number of participants with adverse events (AE) or serious adverse events (SAE)
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) is defined as any untoward medical occurrence at any dose that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect. AEs include both SAEs and AEs.
Time frame: Screening, Baseline through study completion, an average of 11 weeks
Number of participants with clinically meaningful change from baseline in laboratory tests results
Time frame: Screening, Baseline, Day 2, 7 and 14
Number of participants with clinically meaningful change from baseline in vital signs
Number of participants with change from baseline in vital signs including supine blood pressure and pulse rate
Time frame: Screening, Day 1, 2, 7, 14, and 15
Number of participants with clinically meaningful change from baseline in electrocardiogram (ECG) parameters
Time frame: Screening, Day 1, 2, 7, 14 and 15
Maximal plasma concentration (Cmax)
The maximum observed plasma concentration (Cmax) will be observed directly from data.
Time frame: Day 1 and 14
Time to Maximum Plasma Concentration (Tmax)
Tmax will be observed directly from data
Time frame: Day 1 and 14
Area Under the Plasma Concentration-Time Profile From Time Zero (AUCτ) To End of Dosing Interval (AUCt)
AUCτ is summarized by dosing interval and day. Dosing interval is the interval τ between administration of doses of drug.
Time frame: Day 1 and 14
Half-life of PF-07054894
terminal elimination half-life will be calculated based on the measured data
Time frame: Day 14
Observed Accumulation Ratio (Rac)
Rac is calculated as, area under the curve from time zero to end of dosing interval on Day 14 (AUCtau) divided by area under the curve from time zero to end of dosing interval on Day 1 (AUCτ)
Time frame: Day 14
Observed Accumulation Ratio Based on Cmax (Rac,Cmax)
Rac Cmax is calculated as, maximum observed plasma concentration on Day 14 (Cmax) divided by maximum observed plasma concentration on Day 1 (Cmax)
Time frame: Day 14
Trough plasma concentrations (Ctrough)
Time frame: Day 14
Apparent Volume of Distribution (Vz/F) as data permits
Vz/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. VZ/F after oral dose is influenced by the fraction absorbed.
Time frame: Day 14
Apparent Oral Clearance (CL/F)
CL/F is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes
Time frame: Day 14
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