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NCT01950481 · ClinicalTrials.gov registry record · Phase 1
Effect of Hepatic Impairment on LDK378 Pharmacokinetics
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT01950481: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT01950481 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01950481, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
Pharmacokinetics and safety of 750 mg of LDK378 given once orally in subjects with impaired hepatic function and healthy subjects with normal hepatic function.
Primary Outcome
Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects
Interventions
- DRUG LDK378
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2014-01 |
| Est. Completion | 2016-09 |
| Phase | Phase 1 |
What the finished NCT01950481 record still lists
NCT01950481 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 1 intervention - of which LDK378 is the first listed.
NCT01950481 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01950481 about?
NCT01950481 is a clinical study titled "Effect of Hepatic Impairment on LDK378 Pharmacokinetics". Pharmacokinetics and safety of 750 mg of LDK378 given once orally in subjects with impaired hepatic function and healthy subjects with normal hepatic function.
What is the current status of trial NCT01950481?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2014-01. Estimated completion is 2016-09.
What interventions are being tested in trial NCT01950481?
The interventions under investigation include: LDK378 (DRUG).
Who is sponsoring clinical trial NCT01950481?
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 NCT01950481's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 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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