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NCT01429337 · ClinicalTrials.gov registry record · Phase 1
PK and Safety of Midostaurin in Subjects With Impaired Hepatic Function and Subjects With Normal Hepatic Function
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
NCT01429337: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT01429337 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 43 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01429337, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
Study Summary
The purpose of this international study was to assess the effect of varying degrees of impaired hepatic function compared to a normal hepatic function (Child-Pugh classification) on the pharmacokinetics and safety of midostaurin.
Primary Outcome
In subjects with Child Pugh A, Child Pugh B (and matching healthy volunteers) Cmax will be measured at Day 1 and Day 7. In subjects with Child Pugh C (and matching healthy volunteers) Cmax will be measured at Day 1
Interventions
- DRUG Midostaurin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2011-03-07 |
| Est. Completion | 2020-05-09 |
| Phase | Phase 1 |
What the finished NCT01429337 record still lists
NCT01429337 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 1 intervention - of which Midostaurin is the first listed.
NCT01429337 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01429337 about?
NCT01429337 is a clinical study titled "PK and Safety of Midostaurin in Subjects With Impaired Hepatic Function and Subjects With Normal Hepatic Function". The purpose of this international study was to assess the effect of varying degrees of impaired hepatic function compared to a normal hepatic function (Child-Pugh classification) on the pharmacokinetics and safety of midostaurin.
What is the current status of trial NCT01429337?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2011-03-07. Estimated completion is 2020-05-09.
What interventions are being tested in trial NCT01429337?
The interventions under investigation include: Midostaurin (DRUG).
Who is sponsoring clinical trial NCT01429337?
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 NCT01429337's enrollment target sits among peer trials
43 1100th of 2000 higher than 896 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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