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NCT05224609 · ClinicalTrials.gov registry record · Phase 1
A Study to Learn About the Study Medicine (Called Lorlatinib) in People With Liver Dysfunction
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT05224609: Completed Phase 1 study, sponsored by Pfizer.
NCT05224609 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05224609, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Lorlatinib) in health participants. This study is seeking participants who: * Must be male or female of 18 to 75 years of age, inclusive at the time of the study. * Are willing and able to comply with all scheduled visits, treatment plan, and other study procedures. * Have a BMI (body mass index) of 17.5 to 40 kg/m2; and a total body weight \>50 kg (110 lb). * Are capable of giving signed informed consent document. All participants in this study will receive Lorlatinib. Participants will be placed into 1 of 3 cohorts based on their hepatic (liver) function. Participants will take Lorlatinib once by mouth. We will examine the experiences of people receiving the study medicine. This will help us determine if the study medicine is safe and effective. Participants will take part in this study for up to 35 days.
Primary Outcome
PK parameter of lorlatinib to be calculated from the plasma concentration time data.
Interventions
- DRUG Lorlatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2022-04-28 |
| Est. Completion | 2024-08-13 |
| Phase | Phase 1 |
What the finished NCT05224609 record still lists
NCT05224609 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 1 intervention - of which Lorlatinib is the first listed.
NCT05224609 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05224609 about?
NCT05224609 is a clinical study titled "A Study to Learn About the Study Medicine (Called Lorlatinib) in People With Liver Dysfunction". The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Lorlatinib) in health participants. This study is seeking participants who: * Must be male or female of 18 to 75 years of age, inclusive at the time of the study. * Are willing and able to comp...
What is the current status of trial NCT05224609?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2022-04-28. Estimated completion is 2024-08-13.
What interventions are being tested in trial NCT05224609?
The interventions under investigation include: Lorlatinib (DRUG).
Who is sponsoring clinical trial NCT05224609?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05224609's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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