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NCT05478603 · ClinicalTrials.gov registry record · Phase 1
A Study to Understand How the Study Medicine (PF-07081532) is Processed in People With Liver Dysfunction
A Phase 1 study of Healthy Volunteers and Hepatic Impairment, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 2
- Study locations
NCT05478603: Completed Phase 1 study of Healthy Volunteers and Hepatic Impairment, sponsored by Pfizer.
NCT05478603 is a Phase 1 study of Healthy Volunteers and Hepatic Impairment that has completed, run by Pfizer. The registered enrollment target is 24 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05478603, a Phase 1 study of Healthy Volunteers and Hepatic Impairment, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to understand the effects of liver functional impairment on the study medicine (PF-07081532). People with liver functional impairment may process the study medicine differently from healthy people. We are seeking participants who: * Are between 18 and 70 years of age; * Have a BMI (body mass index) of 17.5 to 38.0 kg/m2, inclusive, and a total body weight \>50 kg (110 lbs.). Participants will take the study medicine as a tablet once at the study clinic, and then will stay onsite for about 7 days. During this time, the study team will monitor their treatment experience and take some blood samples to test the level of PF-07081532. This will help us understand if certain level of liver functional impairment could affect the study medicine being processed in the body.
Primary Outcome
Cmax is the maximum plasma concentration.
Conditions Studied
Interventions
- DRUG PF-07081532
Study Locations (2)
Florida
- Orlando Clinical Research Center - Orlando
- Genesis Clinical Research, LLC - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2022-08-01 |
| Est. Completion | 2023-04-05 |
| Phase | Phase 1 |
What the finished NCT05478603 record still lists
NCT05478603 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Healthy Volunteers appearing as the primary indexed condition, and to 1 intervention - of which PF-07081532 is the first listed.
NCT05478603 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05478603 about?
NCT05478603 is a clinical study titled "A Study to Understand How the Study Medicine (PF-07081532) is Processed in People With Liver Dysfunction". The purpose of this study is to understand the effects of liver functional impairment on the study medicine (PF-07081532). People with liver functional impairment may process the study medicine differently from healthy people. We are seeking participants who: * Are between 18 and 70 years of age; ...
What is the current status of trial NCT05478603?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2022-08-01. Estimated completion is 2023-04-05.
What conditions does trial NCT05478603 study?
This clinical trial studies the following conditions: Healthy Volunteers, Hepatic Impairment.
What interventions are being tested in trial NCT05478603?
The interventions under investigation include: PF-07081532 (DRUG).
Who is sponsoring clinical trial NCT05478603?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05478603 being conducted?
This trial has 2 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05478603's enrollment target sits among peer trials
24 204th of 283 higher than 66 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers 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.
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