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NCT04091061 · ClinicalTrials.gov registry record · Phase 1
Effect Of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of PF-06865571 In Subjects With Hepatic Impairment and in Healthy Subjects
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
NCT04091061: Completed Phase 1 study of Healthy Volunteers and Hepatic Impairment, sponsored by Pfizer.
NCT04091061 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
NCT04091061, 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 current study is proposed to evaluate whether there is any clinically meaningful effect of hepatic impairment on the plasma PK of PF-06865571.
Primary Outcome
Cmax of PF-06865571 was observed directly from data.
Conditions Studied
Interventions
- DRUG PF-06865571 100 mg
Study Locations (2)
Florida
- University of Miami Division of Clinical Pharmacology - Miami
- Orlando Clinical Research Center - Orlando
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2019-10-03 |
| Est. Completion | 2020-04-07 |
| Phase | Phase 1 |
What the finished NCT04091061 record still lists
NCT04091061 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-06865571 100 mg is the first listed.
NCT04091061 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT04091061 about?
NCT04091061 is a clinical study titled "Effect Of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of PF-06865571 In Subjects With Hepatic Impairment and in Healthy Subjects". The current study is proposed to evaluate whether there is any clinically meaningful effect of hepatic impairment on the plasma PK of PF-06865571.
What is the current status of trial NCT04091061?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2019-10-03. Estimated completion is 2020-04-07.
What conditions does trial NCT04091061 study?
This clinical trial studies the following conditions: Healthy Volunteers, Hepatic Impairment.
What interventions are being tested in trial NCT04091061?
The interventions under investigation include: PF-06865571 100 mg (DRUG).
Who is sponsoring clinical trial NCT04091061?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04091061 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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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 NCT04091061'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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