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NCT02624557 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic Study of Alpelisib in Subjects With Hepatic Impairment.
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT02624557: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT02624557 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02624557, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
To characterize the pharmacokinetics and safety of alpelisib in subjects with hepatic impairment compared to matched healthy control subjects.
Primary Outcome
Measurement of effect of hepatic impairment on PK of alpelisib by assessment of the maximum plasma concentration (PK parameter Cmax). Cmax directly determined from the plasma concentration-time profile.
Interventions
- DRUG Alpelisib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2015-12-21 |
| Est. Completion | 2017-10-01 |
| Phase | Phase 1 |
What the finished NCT02624557 record still lists
NCT02624557 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 1 intervention - of which Alpelisib is the first listed.
NCT02624557 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02624557 about?
NCT02624557 is a clinical study titled "Pharmacokinetic Study of Alpelisib in Subjects With Hepatic Impairment.". To characterize the pharmacokinetics and safety of alpelisib in subjects with hepatic impairment compared to matched healthy control subjects.
What is the current status of trial NCT02624557?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2015-12-21. Estimated completion is 2017-10-01.
What interventions are being tested in trial NCT02624557?
The interventions under investigation include: Alpelisib (DRUG).
Who is sponsoring clinical trial NCT02624557?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02624557's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 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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