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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours pf-07220060 post-dose
Awards & highlights
Summary
This trial compares two formulations of a medicine (PF-07220060) and how they are absorbed into the bloodstream. It also looks at the effects of food & Rabeprazole medicine on the uptake of the medicine.
Who is the study for?
Healthy adults aged 18-65 with a BMI of 17.5-30.5 kg/m2 and weight over 50 kg can join this study. They must be in good health as confirmed by medical exams, tests, and have no history of conditions affecting drug absorption or serious diseases like HIV or hepatitis.Check my eligibility
What is being tested?
The trial is testing two different tablet forms of PF-07220060 to see how they are absorbed into the bloodstream, with and without food, and under the influence of Rabeprazole (a proton pump inhibitor).See study design
What are the potential side effects?
Potential side effects aren't specified but may include reactions typical for clinical trials such as nausea, headache, digestive issues or allergic reactions depending on individual tolerance to PF-07220060.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours pf-07220060 post-dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours pf-07220060 post-dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time(AUCinf) of PF-07220060 to estimate relative bioavailability of PF-07220060 two tablet formulations
Maximum Observed Plasma Concentration (Cmax) of PF-07220060 to estimate relative bioavailability of PF-07220060 two tablet formulations
Secondary outcome measures
AUCinf of PF-07220060 to estimate relative bioavailability of PF-07220060 two tablet formulations at a second dose level
AUCinf of PF-07220060 to estimate the effect of a PPI (rabeprazole) on the bioavailability of a PF-07220060 tablet formulation under fasted condition
AUCinf of PF-07220060 to estimate the effect of a PPI (rabeprazole) on the bioavailability of a PF-07220060 tablet formulation under fed condition
+11 moreTrial Design
8Treatment groups
Experimental Treatment
Group I: Cohort 8Experimental Treatment1 Intervention
Participants will receive PF-07220060 tablet by mouth
Group II: Cohort 7Experimental Treatment1 Intervention
Participants will receive PF-07220060 and Rabeprazole tablet by mouth
Group III: Cohort 6Experimental Treatment1 Intervention
Participants will receive PF-07220060 and Rabeprazole tablets by mouth
Group IV: Cohort 5Experimental Treatment1 Intervention
Participants will receive PF-07220060 tablet by mouth
Group V: Cohort 4Experimental Treatment1 Intervention
Participants will receive PF-07220060 tablet by mouth
Group VI: Cohort 3Experimental Treatment1 Intervention
Participants will receive PF-07220060 tablet by mouth
Group VII: Cohort 2Experimental Treatment1 Intervention
Participants will receive PF-07220060 tablet by mouth
Group VIII: Cohort 1Experimental Treatment1 Intervention
Participants will receive PF-07220060 tablet by mouth
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
PfizerLead Sponsor
4,595 Previous Clinical Trials
12,868,658 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,496 Previous Clinical Trials
10,045,267 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am generally healthy as confirmed by recent medical exams.I do not have any significant ongoing health issues apart from untreated seasonal allergies.I have a condition that might affect how my body absorbs medication.My BMI is between 17.5 and 30.5, and I weigh more than 110 lbs.I have a history of HIV or hepatitis, or I've tested positive for them. Vaccination for hepatitis B is okay.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 8
- Group 2: Cohort 7
- Group 3: Cohort 2
- Group 4: Cohort 1
- Group 5: Cohort 5
- Group 6: Cohort 3
- Group 7: Cohort 4
- Group 8: Cohort 6
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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