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NCT03542305 · ClinicalTrials.gov registry record · Phase 1
Lorlatinib Renal Impairment Study
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
NCT03542305: Completed Phase 1 study, sponsored by Pfizer.
NCT03542305 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 29 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03542305, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
Study Summary
This is a Phase 1, open-label, multi-center, single treatment study in subjects with normal renal function and varying degrees of renal impairment.
Primary Outcome
AUCinf was calculated by AUClast + (Clast\*/kel), where AUClast was the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration; Clast\* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Interventions
- DRUG Lorlatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2018-08-23 |
| Est. Completion | 2020-02-20 |
| Phase | Phase 1 |
What the finished NCT03542305 record still lists
NCT03542305 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 1 intervention - of which Lorlatinib is the first listed.
NCT03542305 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03542305 about?
NCT03542305 is a clinical study titled "Lorlatinib Renal Impairment Study". This is a Phase 1, open-label, multi-center, single treatment study in subjects with normal renal function and varying degrees of renal impairment.
What is the current status of trial NCT03542305?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2018-08-23. Estimated completion is 2020-02-20.
What interventions are being tested in trial NCT03542305?
The interventions under investigation include: Lorlatinib (DRUG).
Who is sponsoring clinical trial NCT03542305?
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 NCT03542305's enrollment target sits among peer trials
29 1440th of 2000 higher than 554 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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