← Back to Search

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 in each period for approximately 8 hours (each period is 7 days) up to approximately 36 days
Awards & highlights

Study 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.Check my eligibility
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.See study design
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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 in each period for approximately 8 hours (each period is 7 days) up to approximately 36 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 in each period for approximately 8 hours (each period is 7 days) up to approximately 36 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) Following Single Ascending Dose
Number of Participants with Change from Baseline in Electrocardiogram (ECG) Findings
Number of Participants with Clinical Laboratory Abnormalities
+3 more
Secondary outcome measures
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-06954522
Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) of PF-06954522
Maximum Observed Plasma Concentration (Cmax) of PF-06954522
+2 more

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

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor
4,568 Previous Clinical Trials
10,911,860 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,475 Previous Clinical Trials
8,093,028 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Cohort 1 been officially given the go-ahead by the FDA?

"With limited data supporting safety and effectiveness, Cohort 1 recieved a score of 1 in our team's analysis."

Answered by AI

Is there an opportunity for me to join this experiment?

"Eligibility for this study is determined by age (18-65) and general health. Approximately 24 patients are necessary to complete the trial."

Answered by AI

Is this trial open to participants who are aged sixty and above?

"In order to meet the eligibility requirements for this trial, potential participants must be between 18 and 65 years of age. An additional 60 trials are open to those below eighteen while 390 studies target patients over sixty-five."

Answered by AI

Are there still openings for participants in this clinical experiment?

"Affirmative. Clinicaltrials.gov data reveals that the trial, which was initialised on August 30th 2023, is still seeking participants. 24 patients from 1 centre must be enrolled for this medical study to reach completion."

Answered by AI

How extensive is the list of participants in this clinical trial?

"Affirmative. Information hosted on clinicaltrials.gov shows that this investigation has commenced its recruitment process, having first been posted and then updated on August 30th 2023 and September 6th 2023 respectively. A total of 24 participants are required from a single site in order to complete the trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Learn How Different Amounts of the Study Medicine Called PF-06954522 Are Tolerated and Act in the Body in Healthy Adults
2023. "A Study to Learn How Different Amounts of the Study Medicine Called PF-06954522 Are Tolerated and Act in the Body in Healthy Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06003777.
~16 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top