A Study to Learn About the Study Medicine Called PF-07054894 in People of Japanese Origin

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

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 Overview

• Status: Not yet recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: PF-07054894 or placebo

• Study Type: Interventional
• Enrollment (Estimated): 6
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• Belgium
  • Bruxelles-capitale, Région DE
    • Brussels, Bruxelles-capitale, Région DE, Belgium, B-1070
      • Pfizer Clinical Research Unit - Brussels

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: PF-07054894 or placebo; multiple oral doses of PF-07054894 for 14 days
Experimental: PF-07054894	Drug: PF-07054894 or placebo; multiple oral doses of PF-07054894 for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Screening, Baseline through study completion, an average of 11 weeks
Number of participants with clinically meaningful change from baseline in laboratory tests results		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	Screening, Day 1, 2, 7, 14, and 15
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)	The maximum observed plasma concentration (Cmax) will be observed directly from data.	Day 1 and 14
Time to Maximum Plasma Concentration (Tmax)	Tmax will be observed directly from data	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.	Day 1 and 14
Half-life of PF-07054894	terminal elimination half-life will be calculated based on the measured data	Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	Day 14
Trough plasma concentrations (Ctrough)		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.	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	Day 14

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Estimated): May 13, 2024
• Primary Completion (Estimated): July 2, 2024
• Study Completion (Estimated): July 2, 2024

Study Registration Dates

• First Submitted: March 18, 2024
• First Submitted That Met QC Criteria: March 18, 2024
• First Posted (Actual): March 25, 2024

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: C4151006; 2023-509339-17-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No