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Completed

NCT Number: NCT06327880

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

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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit - Brussels

Brussels, Bruxelles-capitale, Région de, B-1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-07054894 or placebo

Drug

multiple oral doses of PF-07054894 for 14 days

Primary outcomes

  1. 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.

  2. Number of participants with clinically meaningful change from baseline in laboratory tests results

    Time frame: Screening, Baseline, Day 2, 7 and 14

  3. 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

  4. Number of participants with clinically meaningful change from baseline in electrocardiogram (ECG) parameters

    Time frame: Screening, Day 1, 2, 7, 14 and 15

  5. Maximal plasma concentration (Cmax)

    Time frame: Day 1 and 14

    The maximum observed plasma concentration (Cmax) will be observed directly from data.

  6. Time to Maximum Plasma Concentration (Tmax)

    Time frame: Day 1 and 14

    Tmax will be observed directly from data

  7. 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.

  8. Half-life of PF-07054894

    Time frame: Day 14

    terminal elimination half-life will be calculated based on the measured data

Secondary outcomes

  1. Observed Accumulation Ratio (Rac)

    Time frame: 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)

  2. Observed Accumulation Ratio Based on Cmax (Rac,Cmax)

    Time frame: 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)

  3. Trough plasma concentrations (Ctrough)

    Time frame: Day 14

  4. Apparent Volume of Distribution (Vz/F) as data permits

    Time frame: 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.

  5. Apparent Oral Clearance (CL/F)

    Time frame: Day 14

    CL/F is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 25, 2024
Registry last updated
Aug 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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