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NCT05005312 · ClinicalTrials.gov registry record · Phase 1
Study to Estimate the Effects of Hepatic Impairment on the Pharmacokinetics (PK) of PF-07321332
A Phase 1 study of Hepatic Impairment, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
- 2
- Study locations
NCT05005312: Completed Phase 1 study of Hepatic Impairment, sponsored by Pfizer.
NCT05005312 is a Phase 1 study of Hepatic Impairment that has completed, run by Pfizer. The registered enrollment target is 17 participants, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (53% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05005312, a Phase 1 study of Hepatic Impairment, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
- 2
- Study locations
Study Summary
The study is to estimate the effect of hepatic impairment on the plasma PK of PF-07321332/ritonavir. Findings from this study will be used to develop dosing recommendations so that the dose and/or dosing interval may be adjusted appropriately in the presence of hepatic impairment.
Primary Outcome
Cmax was the maximum observed plasma concentration and was directly observed from data. Concentration values below the lower limit of quantification (LLQ) were set to zero. Geometric mean analysis was on the log scale. Zero values were not included in geometric mean and geometric coefficient of variation calculation. The geometric coefficient of variation was expressed in percentage.
Conditions Studied
Interventions
- DRUG Ritonavir
- DRUG PF-07321332
Study Locations (2)
California
- Orange County Research Center - Tustin
Minnesota
- Prism Research LLC dba Nucleus Network - Saint Paul
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2021-08-31 |
| Est. Completion | 2021-12-07 |
| Phase | Phase 1 |
What the finished NCT05005312 record still lists
NCT05005312 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (53% lower).
The record links to 1 condition, with Hepatic Impairment appearing as the primary indexed condition, and to 2 interventions - of which Ritonavir is the first listed.
NCT05005312 reports a single indexed study location in California, Minnesota.
Frequently Asked Questions
What is clinical trial NCT05005312 about?
NCT05005312 is a clinical study titled "Study to Estimate the Effects of Hepatic Impairment on the Pharmacokinetics (PK) of PF-07321332". The study is to estimate the effect of hepatic impairment on the plasma PK of PF-07321332/ritonavir. Findings from this study will be used to develop dosing recommendations so that the dose and/or dosing interval may be adjusted appropriately in the presence of hepatic impairment.
What is the current status of trial NCT05005312?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2021-08-31. Estimated completion is 2021-12-07.
What conditions does trial NCT05005312 study?
This clinical trial studies the following conditions: Hepatic Impairment.
What interventions are being tested in trial NCT05005312?
The interventions under investigation include: Ritonavir (DRUG), PF-07321332 (DRUG).
Who is sponsoring clinical trial NCT05005312?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05005312 being conducted?
This trial has 2 study locations across California, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hepatic Impairment
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05005312's enrollment target sits among peer trials
17 45th of 48 higher than 4 of 48 other Hepatic Impairment trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatic Impairment trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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