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NCT05884554 · ClinicalTrials.gov registry record · Phase 1
A Study to Learn About How Loss of Liver Function Affects the Blood Levels of the Study Medicine Called PF-07817883.
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT05884554 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 21 participants.
The verdict
NCT05884554, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
The purpose of the study is to learn about the safety of PF-07817883 and how PF-07817883 is processed in the body of adult participants. These participants will have different degrees of loss of liver function. Participants with mild, moderate, severe or no loss of liver function will be enrolled in 4 groups. This study is seeking participants who: * are male or female of 18- 75 years of age * either have different amounts of damage to liver function or for one of the groups, no damage * willing to follow the requirements of the study including stay at clinic for 6 nights and 7 days About, 6-8 participants will be enrolled in group 1 (participants without loss of liver function) and group 3 (participants with moderate loss of liver function). In group 4 (participants with severe loss of function), around 4 to 8 participants will be enrolled. Participants in group 2 (mild loss of function) will only be enrolled after review of the data from groups 3 and 4. If participants consent to participate in the study, it may take up to 4 weeks to complete all the tests to confirm if they are eligible to participate in the study. If they seem to be eligible for the study, participants will be admitted to a clinic research unit (CRU) at least 12 hours before dosing. On Day 1, participants will receive a single dose of study medicine (Day 1). A series of blood samples will be collected before and after dosing. Participants will be discharged from the CRU on Day 6. A follow-up phone call (on CRU visit, if needed), will occur 28-35 days after dosing. The whole study will last for a minimum of 5 weeks and a maximum of 10 weeks.
Interventions
- DRUG PF-07817883
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2023-06-15 |
| Est. Completion | 2024-06-27 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05884554
The ClinicalTrials.gov registry entry for NCT05884554 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which PF-07817883 is the first listed.
NCT05884554 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05884554 about?
NCT05884554 is a clinical study titled "A Study to Learn About How Loss of Liver Function Affects the Blood Levels of the Study Medicine Called PF-07817883.". The purpose of the study is to learn about the safety of PF-07817883 and how PF-07817883 is processed in the body of adult participants. These participants will have different degrees of loss of liver function. Participants with mild, moderate, severe or no loss of liver function will be enrolled in...
What is the current status of trial NCT05884554?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2023-06-15. Estimated completion is 2024-06-27.
What interventions are being tested in trial NCT05884554?
The interventions under investigation include: PF-07817883 (DRUG).
Who is sponsoring clinical trial NCT05884554?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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