Healthy
Conditions
Brief summary
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.
Interventions
DRUGPF-07054894 or placebo
multiple oral doses of PF-07054894 for 14 days
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and female Japanese subjects aged 18 years or older * Body Mass Index (BMI) of 16-32 kg/m2; and a total body weight \>45 kg (100 lb)
Exclusion criteria
* Evidence or history of clinically significant disease or medical conditions * Positive urine drug test or history of alcohol abuse or illicit drug use.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Half-life of PF-07054894 | Day 14 | terminal elimination half-life will be calculated based on the measured data |
| Number of participants with clinically meaningful change from baseline in vital signs | Screening, Day 1, 2, 7, 14, and 15 | Number of participants with change from baseline in vital signs including supine blood pressure and pulse rate |
| Number of participants with clinically meaningful change from baseline in electrocardiogram (ECG) parameters | Screening, Day 1, 2, 7, 14 and 15 | — |
| Maximal plasma concentration (Cmax) | Day 1 and 14 | The maximum observed plasma concentration (Cmax) will be observed directly from data. |
| Time to Maximum Plasma Concentration (Tmax) | Day 1 and 14 | Tmax will be observed directly from data |
| Area Under the Plasma Concentration-Time Profile From Time Zero (AUCτ) To End of Dosing Interval (AUCt) | Day 1 and 14 | AUCτ is summarized by dosing interval and day. Dosing interval is the interval τ between administration of doses of drug. |
| Number of participants with adverse events (AE) or serious adverse events (SAE) | Screening, Baseline through study completion, an average of 11 weeks | 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. |
| Number of participants with clinically meaningful change from baseline in laboratory tests results | Screening, Baseline, Day 2, 7 and 14 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Observed Accumulation Ratio Based on Cmax (Rac,Cmax) | Day 14 | Rac Cmax is calculated as, maximum observed plasma concentration on Day 14 (Cmax) divided by maximum observed plasma concentration on Day 1 (Cmax) |
| Trough plasma concentrations (Ctrough) | Day 14 | — |
| Apparent Volume of Distribution (Vz/F) as data permits | Day 14 | 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. |
| Apparent Oral Clearance (CL/F) | Day 14 | CL/F is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes |
| Observed Accumulation Ratio (Rac) | Day 14 | 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) |
Countries
Belgium
Outcome results
None listed