Completed

A PHASE 1, OPEN-LABEL, RANDOMIZED, 5-PERIOD, 6-SEQUENCE, CROSSOVER STUDY TO COMPARE THE SINGLE-DOSE PHARMACOKINETICS OF IMMEDIATE-RELEASE AND MODIFIED-RELEASE FORMULATIONS OF PF-06954522 ADMINISTERED ORALLY TO HEALTHY ADULT PARTICIPANTS

What is being tested

PF-06954522 IR (Formulation 1)

+ PF-06954522 MR (Formulation 2)

+ PF-06954522 MR (Formulation 3)

Drug

Who is being recruted

Over 18 Years

+7 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: April 2024

See protocol details

Summary

Principal SponsorPfizer

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: April 30, 2024

Actual date on which the first participant was enrolled.

This study aims to compare how different formulations of a drug called PF-06954522 enter the bloodstream when taken by mouth. It focuses on healthy adults, both male and female, aged 18 and older. Understanding how these different versions of the medication are absorbed can help determine the most effective way to administer the drug. This could lead to improved dosing strategies and better outcomes for those who may eventually need this medication for treatment in the future. Participants in the study will take PF-06954522 orally in tablet form. They will receive different formulations of the medication to see how each is absorbed into the bloodstream. The study lasts about 77 days, with participants staying at the study site for 21 days. There will also be a follow-up phone call after this period. This study does not list specific risks or benefits, but it involves closely monitoring how the drug is processed in the body.

Official TitleA PHASE 1, OPEN-LABEL, RANDOMIZED, 5-PERIOD, 6-SEQUENCE, CROSSOVER STUDY TO COMPARE THE SINGLE-DOSE PHARMACOKINETICS OF IMMEDIATE-RELEASE AND MODIFIED-RELEASE FORMULATIONS OF PF-06954522 ADMINISTERED ORALLY TO HEALTHY ADULT PARTICIPANTS

NCT06393517

Principal SponsorPfizer

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

23 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate

Male and female participants of non-childbearing potential aged 18 years or older who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and electrocardiograms.

Body mass index of 16-32 kg/m2; and a total body weight >50 kg (110 lbs).

5 exclusion criteria prevent from participating

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).

Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2, or participants with suspected MTC per the investigator's judgement.

Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

Use of any prohibited prior/concomitant medication(s).

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

6 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Participants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as: Formulation 1 , Formulation 2, and Formulation 3 under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 2 and 3 under fed conditions in Periods 4 and 5, respectively.

Group II

Experimental

Participants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as: Formulation 2, Formulation 3, and Formulation 1 under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 2 and 3 under fed conditions in Periods 4 and 5, respectively.

Group III

Experimental

Participants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as: Formulation 3, Formulation 1, and Formulation 2, under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 2 and 3 under fed conditions in Periods 4 and 5, respectively.

Group IV

Experimental

Participants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as: Formulation 3, Formulation 2, and Formulation 1 under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 3 and 2 under fed conditions in Periods 4 and 5, respectively.

Group 5

Experimental

Participants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as: Formulation 1, Formulation 3, and Formulation 2 under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 3 and 2 under fed conditions in Periods 4 and 5, respectively.

Group 6

Experimental

Participants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as: Formulation 2, Formulation 1, and Formulation 3 under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 3 and 2 under fed conditions in Periods 4 and 5, respectively.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Pfizer Clinical Research Unit - New Haven

New Haven, United StatesOpen Pfizer Clinical Research Unit - New Haven in Google Maps

Suspended

Pfizer Clinical Research Unit

New Haven, United States

Completed2 Study Centers