A Study to Understand What the Body Does to the Study Medicine Called PF-07220060 When Taken by H… (NCT06267963) | Clinical Trial Compass
CompletedPhase 1
A Study to Understand What the Body Does to the Study Medicine Called PF-07220060 When Taken by Healthy Adults
Netherlands12 participantsStarted 2024-01-31
Plain-language summary
The purpose of this study is to learn about how much PF-07220060 will be taken up and processed by healthy male participants.
The study is seeking for participants who:
* are males aged 18 to 65 years and are healthy.
* have Body mass index (BMI) between 17.5 and 30.5 kilograms/meter2
* have a total body weight of at least 50 kilograms.
The study consists of two groups. In group 1, participants will take one amount of PF-07220060 by mouth. In group 2, participants will take one amount by mouth and one amount as an injection through a vein at the study clinic.
In group 1, participants will stay at the clinic site for up to 15 days. In group 2, the duration of participants' stay depends on the results of group 1.
During their stays, participants will have their blood, urine, and feces collected by the study doctors several times. We will measure the level of PF-07220060 in participants' blood, urine, and feces samples. This will help to know how much the study medicine is getting taken up by the body. At the end of the study, participants will be contacted by phone to check in. Participants will be involved in this study for about 9 weeks from the screening until the follow-up.
Who can participate
Age range
18 Years – 65 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Eligibility criteria for this study include, but are not limited to the following:
Inclusion Criteria:
* Male participants aged 18 to 65 years at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
* Body mass index (BMI) of 17.5-30.5 kg/m2; and a total body weight \>50 kg (110 lb).
* Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
Exclusion Criteria:
* Participants with a history of irregular bowel movements (eg, regular episodes of diarrhea or constipation, irritable bowel syndrome \[IBS\] or lactose intolerance).
* Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives (whichever is longer) preceding the first dose of study intervention used in this study. Previous exposure to PF-07220060 or participation in studies requiring PF-07220060 administration.
* Total 14C radioactivity measured in plasma exceeding 11 mBq/mL.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Total Radiocarbon (14C) Excreted in Urine
Timeframe: From Predose up to 14 days post-dose
2
Percentage of Total Radiocarbon (14C) Excreted in Feces: Cohort 1
Timeframe: From Predose up to 14 days post-dose
3
Cumulative Percent Recovery of Total Radiocarbon (14C)
Timeframe: From Predose up to 14 days post-dose
4
Percentage of Metabolite Detected in Plasma After Oral Administration of PF-07220060: Cohort 1
Timeframe: From Predose up to 96 hours post-dose
5
Percentage of Metabolite Detected in Urine After Oral Administration of PF-07220060: Cohort 1
Timeframe: From Predose up to 144 hours post-dose
6
Percentage of Metabolite Detected in Feces After Oral Administration of PF-07220060: Cohort 1
Timeframe: From Predose up to 196 hours post-dose
7
Percentage of Metabolite Detected in Feces After IV Administration of PF-07220060: Cohort 2