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NCT04909853 · ClinicalTrials.gov registry record · Phase 1
Renal Impairment Study of PF-07321332 Boosted With Ritonavir in Adult Participants With Renal Impairment and in Healthy Participants With Normal Renal Function.
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
NCT04909853 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 35 participants.
The verdict
NCT04909853, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
Study Summary
This is a Phase 1, non-randomized, open-label, 2-part study to investigate the effect of renal impairment on the pharmacokinetics (PK), safety and tolerability of a single oral dose of PF-07321332 in combination with the PK boosting agent ritonavir. Participants will be selected and categorized into normal renal function or renal impairment groups based on their estimated glomerular filtration rate. Part 1: will be conducted in approximately 24 participants (approximately 8 per group) with stable mild or moderate renal impairment and a control group of participants with normal renal function. Part 2 will be conducted in approximately 8 participants with stable severe renal impairment.
Interventions
- DRUG PF-07321332/ritonavir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2021-06-15 |
| Est. Completion | 2021-10-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04909853
The ClinicalTrials.gov registry entry for NCT04909853 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 35 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-07321332/ritonavir is the first listed.
NCT04909853 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04909853 about?
NCT04909853 is a clinical study titled "Renal Impairment Study of PF-07321332 Boosted With Ritonavir in Adult Participants With Renal Impairment and in Healthy Participants With Normal Renal Function.". This is a Phase 1, non-randomized, open-label, 2-part study to investigate the effect of renal impairment on the pharmacokinetics (PK), safety and tolerability of a single oral dose of PF-07321332 in combination with the PK boosting agent ritonavir. Participants will be selected and categorized into...
What is the current status of trial NCT04909853?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2021-06-15. Estimated completion is 2021-10-07.
What interventions are being tested in trial NCT04909853?
The interventions under investigation include: PF-07321332/ritonavir (DRUG).
Who is sponsoring clinical trial NCT04909853?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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