Clinical trial NCT06327880: A Study to Learn About the Study Medicine Called PF-07054894 in People of Japanese Origin
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-03-25
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Number of participants with adverse events (AE) or serious adverse events (SAE)
timeFrame: Screening, Baseline through study completion, an average of 11 weeks
measure: Number of participants with clinically meaningful change from baseline in laboratory tests results
timeFrame: Screening, Baseline, Day 2, 7 and 14
measure: Number of participants with clinically meaningful change from baseline in vital signs
timeFrame: Screening, Day 1, 2, 7, 14, and 15
measure: Number of participants with clinically meaningful change from baseline in electrocardiogram (ECG) parameters
timeFrame: Screening, Day 1, 2, 7, 14 and 15
measure: Maximal plasma concentration (Cmax)
timeFrame: Day 1 and 14
measure: Time to Maximum Plasma Concentration (Tmax)
timeFrame: Day 1 and 14
measure: Area Under the Plasma Concentration-Time Profile From Time Zero (AUCτ) To End of Dosing Interval (AUCt)
timeFrame: Day 1 and 14
measure: Half-life of PF-07054894
timeFrame: Day 14
Secondary outcomes:
measure: Observed Accumulation Ratio (Rac)
timeFrame: Day 14
measure: Observed Accumulation Ratio Based on Cmax (Rac,Cmax)
timeFrame: Day 14
measure: Trough plasma concentrations (Ctrough)
timeFrame: Day 14
measure: Apparent Volume of Distribution (Vz/F) as data permits
timeFrame: Day 14
measure: Apparent Oral Clearance (CL/F)
timeFrame: Day 14
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Pfizer Clinical Research Unit - Brussels
state: Bruxelles-capitale, Région DE
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: