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NCT06586216 · ClinicalTrials.gov registry record · Phase 1
A Study to Learn How Renal Impairment Affects the Pharmacokinetics of PF-07817883.
A Phase 1 study of COVID-19, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 3
- Study locations
NCT06586216: Completed Phase 1 study of COVID-19, sponsored by Pfizer.
NCT06586216 is a Phase 1 study of COVID-19 that has completed, run by Pfizer. The registered enrollment target is 16 participants, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06586216, a Phase 1 study of COVID-19, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of the study is to learn about: * how PF-07817883 is processed in the body of adult participants. * the safety of PF-07817883. These participants will have different levels of kidney function loss: * moderate * severe * none or healthy Participants with moderate, severe or no loss of kidney function may be taken into one of 3 groups. This study is seeking for participants who: * are male or female of 18 to 90 years of age. * have different levels of damage to kidney function or for one of the groups, no damage * are willing to follow the requirements of the study including stay at clinic for 5 nights and 6 days. About, 8 participants may be selected in groups 2 and 3. In group 1, around 8 to 12 participants may be selected. If participants agree to take part in the study, it may take up to 4 weeks to complete all the tests to confirm if they are fit to be in the study. If they seem to be fit for the study, participants will be admitted to a clinic research unit (CRU) at least 8 hours before dosing. On Day 1, participants will receive a single amount of study medicine (Day 1). A series of blood samples will be collected before and after giving medicines. Participants will be discharged from the CRU on Day 5. A follow-up phone call (or CRU visit, if needed), will occur 28-35 days after taking the medicine. The whole study will last for a minimum of 5 weeks and a maximum of 10 weeks.
Primary Outcome
Plasma PF-07817883 PK parameters
Conditions Studied
Interventions
- DRUG PF-07817883
Study Locations (3)
Florida
- Clinical Pharmacology of Miami - Miami
- Genesis Clinical Research, LLC - Tampa
Minnesota
- Prism Research LLC dba Nucleus Network - Saint Paul
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2024-09-10 |
| Est. Completion | 2025-02-13 |
| Phase | Phase 1 |
What the finished NCT06586216 record still lists
NCT06586216 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower).
The record links to 1 condition, with COVID-19 appearing as the primary indexed condition, and to 1 intervention - of which PF-07817883 is the first listed.
NCT06586216 reports a single indexed study location in Florida, Minnesota.
Frequently Asked Questions
What is clinical trial NCT06586216 about?
NCT06586216 is a clinical study titled "A Study to Learn How Renal Impairment Affects the Pharmacokinetics of PF-07817883.". The purpose of the study is to learn about: * how PF-07817883 is processed in the body of adult participants. * the safety of PF-07817883. These participants will have different levels of kidney function loss: * moderate * severe * none or healthy Participants with moderate, severe or no loss of ...
What is the current status of trial NCT06586216?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2024-09-10. Estimated completion is 2025-02-13.
What conditions does trial NCT06586216 study?
This clinical trial studies the following conditions: COVID-19.
What interventions are being tested in trial NCT06586216?
The interventions under investigation include: PF-07817883 (DRUG).
Who is sponsoring clinical trial NCT06586216?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06586216 being conducted?
This trial has 3 study locations across Florida, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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