A PHASE 1, RANDOMIZED, DOUBLE BLIND, SPONSOR OPEN, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF MULTIPLE ORAL DOSES OF PF-07054894 IN HEALTHY ADULT JAPANESE PARTICIPANTS
Overview
- Phase
- Phase 1
- Intervention
- PF-07054894 or placebo
- Conditions
- Healthy
- Sponsor
- Pfizer
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Number of participants with adverse events (AE) or serious adverse events (SAE)
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
PF-07054894
Intervention: PF-07054894 or placebo
Placebo
Intervention: PF-07054894 or placebo
Outcomes
Primary Outcomes
Number of participants with adverse events (AE) or serious adverse events (SAE)
Time Frame: 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.
Time to Maximum Plasma Concentration (Tmax)
Time Frame: Day 1 and 14
Tmax will be observed directly from data
Half-life of PF-07054894
Time Frame: Day 14
terminal elimination half-life will be calculated based on the measured data
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
Time Frame: 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
Maximal plasma concentration (Cmax)
Time Frame: Day 1 and 14
The maximum observed plasma concentration (Cmax) will be observed directly from data.
Number of participants with clinically meaningful change from baseline in electrocardiogram (ECG) parameters
Time Frame: Screening, Day 1, 2, 7, 14 and 15
Area Under the Plasma Concentration-Time Profile From Time Zero (AUCτ) To End of Dosing Interval (AUCt)
Time Frame: Day 1 and 14
AUCτ is summarized by dosing interval and day. Dosing interval is the interval τ between administration of doses of drug.
Secondary Outcomes
- Apparent Volume of Distribution (Vz/F) as data permits(Day 14)
- Apparent Oral Clearance (CL/F)(Day 14)
- Observed Accumulation Ratio (Rac)(Day 14)
- Observed Accumulation Ratio Based on Cmax (Rac,Cmax)(Day 14)
- Trough plasma concentrations (Ctrough)(Day 14)