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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 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 43 participants.
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.
Interventions
- DRUG Midostaurin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2011-03-07 |
| Est. Completion | 2020-05-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01429337
The ClinicalTrials.gov registry entry for NCT01429337 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Midostaurin is the first listed.
NCT01429337 reports 0 study locations.
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.
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