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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female participants of non-child bearing potential and males must be 18 to 60 years of age, inclusive, at the time of signing the Informed Consent Document (ICD).
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 38, and 72 hours post dose on day 14
Awards & highlights
Study Summary
This trial studies the safety, effectiveness of a new drug, given as a pill or suspension, to healthy participants. It includes 2 parts with up to 12 weeks for each.
Who is the study for?
Healthy adults aged 18-60, with a BMI of 20.0 to 35.0 kg/m2 and weight over 50 kg (110 lbs), can join this study. Women must be incapable of childbearing. Participants should not have conditions affecting drug absorption, active infections like HIV or hepatitis, recent use of other drugs or supplements, high blood pressure, renal impairment, significant ECG abnormalities, history of substance abuse within the last six months or certain medical conditions.Check my eligibility
What is being tested?
The trial is testing PF-07328948's safety and how it's processed in the body when given multiple times to healthy people (Part A) and comparing its availability in the body between pill form versus suspension (Part B). Part B will proceed if Part A results are promising. Participants will receive either PF-07328948 or a placebo randomly.See study design
What are the potential side effects?
Specific side effects aren't listed but generally include reactions related to safety and tolerability such as potential allergic reactions, gastrointestinal issues due to drug absorption processes being studied, fatigue from participation requirements or possible headaches.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 60 years old and cannot have children or am a male.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ predose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 38, and 72 hours post dose on day 14
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 38, and 72 hours post dose on day 14
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part A: Number of Participants With Cardiac Rhythms of Potential Clinical Concern Assessed By Telemetry
Part A: Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings
Part A: Number of Participants With Change From Baseline in Physical Examination Findings
+6 moreSecondary outcome measures
Part A: Amount of PF-07328948 Excreted Unchanged in Urine Over the Dosing Interval Tau (Aetau)
Part A: Area Under the Plasma Concentration-Time Curve From Time 0 to Dosing Interval (tau) (AUCtau) of PF-07328948
Part A: Maximum Observed Plasma Concentration (Cmax) of PF-07328948
+15 moreTrial Design
11Treatment groups
Experimental Treatment
Group I: PF-07328948 oral tablet and oral suspension (Cohort 11)Experimental Treatment1 Intervention
Assessment of relative bioavailability PF-07328948 oral tablet compared to PF-07328948 oral suspension under fed and fasted condition; 12 participants will be enrolled, and 6 participants randomized to 1 of 2 sequences
Group II: PF-07328948 and Placebo (Cohort 9)Experimental Treatment2 Interventions
Optional cohort - Dose level TBD. Multiple dose administration of PF-07328948 and placebo over 14 days in healthy participants; 8 participants will receive PF-07328948 and 2 will receive placebo
Group III: PF-07328948 and Placebo (Cohort 8)Experimental Treatment2 Interventions
Optional cohort - Dose level TBD. Multiple dose administration of PF-07328948 and placebo over 14 days in healthy participants; 8 participants will receive PF-07328948 and 2 will receive placebo
Group IV: PF-07328948 and Placebo (Cohort 7)Experimental Treatment2 Interventions
Dose level 7: Multiple dose administration of PF-07328948 and placebo over 14 days in healthy participants; 8 participants will receive PF-07328948 and 2 will receive placebo
Group V: PF-07328948 and Placebo (Cohort 6)Experimental Treatment2 Interventions
Dose level 6: Multiple dose administration of PF-07328948 and placebo over 14 days in healthy participants; 8 participants will receive PF-07328948 and 2 will receive placebo
Group VI: PF-07328948 and Placebo (Cohort 5)Experimental Treatment2 Interventions
Dose level 5: Multiple dose administration of PF-07328948 and placebo over 14 days in healthy participants; 8 participants will receive PF-07328948 and 2 will receive placebo
Group VII: PF-07328948 and Placebo (Cohort 4)Experimental Treatment2 Interventions
Dose level 4: Multiple dose administration of PF-07328948 and placebo over 14 days in healthy participants; 8 participants will receive PF-07328948 and 2 will receive placebo
Group VIII: PF-07328948 and Placebo (Cohort 3)Experimental Treatment2 Interventions
Dose level 3: Multiple dose administration of PF-07328948 and placebo over 14 days in healthy participants; 8 participants will receive PF-07328948 and 2 will receive placebo
Group IX: PF-07328948 and Placebo (Cohort 2)Experimental Treatment2 Interventions
Dose level 2: Multiple dose administration of PF-07328948 and placebo over 14 days in healthy participants; 8 participants will receive PF-07328948 and 2 will receive placebo
Group X: PF-07328948 and Placebo (Cohort 10)Experimental Treatment2 Interventions
Optional cohort - Multiple dose administration of PF-07328948 and placebo over 14 days in healthy Japanese participants; 5 participants will receive PF-07328948 and 1 will receive placebo
Group XI: PF-07328948 and Placebo (Cohort 1)Experimental Treatment2 Interventions
Dose level 1: Multiple dose administration of PF-07328948 and placebo over 14 days in healthy participants; 8 participants will receive PF-07328948 and 2 will receive placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
PF-07328948
2022
Completed Phase 1
~20
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
PfizerLead Sponsor
4,570 Previous Clinical Trials
10,915,853 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,476 Previous Clinical Trials
8,092,049 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 60 years old and cannot have children or am a male.My kidney function is reduced, with an eGFR below 75 mL/min.My BMI is between 20.0 and 35.0, and I weigh more than 110 lbs.I have a condition that might affect how my body absorbs medication.I am willing and able to follow all study requirements.You have any medical or mental health conditions, including recent thoughts of self-harm or abnormal lab results, or any other situations related to the COVID-19 pandemic that could make it risky for you to participate in the study.I haven't taken any drugs or supplements within 7 days or 5 half-lives before starting the study treatment.I am a healthy male or a female not able to have children, confirmed by medical tests.I have a history of HIV, hepatitis B, or hepatitis C.I have a significant medical condition other than my cancer.
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: PF-07328948 and Placebo (Cohort 3)
- Group 2: PF-07328948 and Placebo (Cohort 8)
- Group 3: PF-07328948 and Placebo (Cohort 9)
- Group 4: PF-07328948 and Placebo (Cohort 1)
- Group 5: PF-07328948 and Placebo (Cohort 2)
- Group 6: PF-07328948 and Placebo (Cohort 6)
- Group 7: PF-07328948 and Placebo (Cohort 10)
- Group 8: PF-07328948 and Placebo (Cohort 4)
- Group 9: PF-07328948 and Placebo (Cohort 5)
- Group 10: PF-07328948 and Placebo (Cohort 7)
- Group 11: PF-07328948 oral tablet and oral suspension (Cohort 11)
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any age restrictions on who may participate in this experiment?
"As specified in the study requirements, only persons aged 18 or higher but below 60 may take part."
Answered by AI
Can I qualify for the experiment?
"Candidates for this trial must fulfil the requirement of being between 18 and 60 years old and in good health. The number of participants that will be accepted totals 88 individuals."
Answered by AI
Do the doors to this research program remain open for new participants?
"This investigation is still open to potential participants, as indicated by the data posted on clinicaltrials.gov. The trial was first made available on April 5th 2023 and has been updated most recently on April 21st of this same year."
Answered by AI
What is the standing of PF-07328948 oral tablet and suspension (Cohort 9) in regards to regulatory acceptance?
"Due to the limited safety and efficacy data demonstrated in Phase 1, our team assigned PF-07328948 oral tablet/suspension (Cohort 9) a score of 1 on our scale from 1 to 3."
Answered by AI
What is the current enrollment number for this research endeavor?
"Affirmative, the details provided on clinicaltrials.gov signify that this research is actively recruiting volunteers. This study was posted to the website on April 5th 2023 and had its last update occur two weeks later. For completion of this trial, 88 patients need to be recruited from a single centre."
Answered by AI
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