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PF-06954522 Tolerance Study in Healthy Adults

Phase 1

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

BMI of 16 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

Be older than 18 years old

Must not have

Standard 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results

Renal impairment as defined by an estimated glomerular filtration rate (eGFR) of <75 mL/min/1.73 m².

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial is testing a new medication to see if it has any important side effects & measure how it affects people. Participants will receive meds & placebo, monitored for 36 days & stay at CRU for 20 days.

Who is the study for?

This trial is for healthy adults aged 18-65, with a BMI of 16 to 30.5 and weight over 50 kg (110 lbs). Women must be unable to bear children. Participants should not have used any drugs or supplements recently and must not have significant health issues as determined by medical tests.

What is being tested?

The study tests PF-06954522, a new medicine taken orally, against a placebo (a pill without medicine) to understand how different doses are tolerated and how they affect the body, including measuring levels in the blood after intake.

What are the potential side effects?

Potential side effects from PF-06954522 aren't fully known yet but could include unexpected reactions that will be monitored through participant feedback and lab results during the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort 3Experimental Treatment2 Interventions

Single dose administration of PF-06954522 and placebo. Participants will receive up to 2 dose levels of PF-06954522 and up to 1 dose level of matching placebo.

Group II: Cohort 2Experimental Treatment2 Interventions

Single dose administration of PF-06954522 and placebo. Participants will receive up to 4 dose levels of PF-06954522 and up to 2 dose levels of matching placebo.

Group III: Cohort 1Experimental Treatment2 Interventions

Single dose administration of PF-06954522 and placebo. Participants will receive up to 5 dose levels of PF-06954522 and up to 2 dose levels of matching placebo.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PF-06954522

2023

Completed Phase 1

~30

Placebo

1995

Completed Phase 3

~2670