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

NCT06327880 | Completed Phase 1 FDA Drug

• 2 other identifiers: C41510062023-509339-17-00
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (5)

• Observed Accumulation Ratio (Rac)

  Day 14

• Observed Accumulation Ratio Based on Cmax (Rac,Cmax)

  Day 14

• Trough plasma concentrations (Ctrough)

  Day 14

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

  Day 14

• Apparent Oral Clearance (CL/F)

  Day 14

Study Arms (2)

PF-07054894

EXPERIMENTAL

Drug: PF-07054894 or placebo

Placebo

PLACEBO COMPARATOR

Drug: PF-07054894 or placebo

Interventions

PF-07054894 or placebo DRUG

multiple oral doses of PF-07054894 for 14 days

PF-07054894; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Evidence or history of clinically significant disease or medical conditions
• Positive urine drug test or history of alcohol abuse or illicit drug use.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit - Brussels

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

Location

Related Links

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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 25, 2024
• Study Start: May 13, 2024
• Primary Completion: July 2, 2024
• Study Completion: July 2, 2024
• Last Updated: August 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)