Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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.

View on ClinicalTrials.gov ↗

View your shortlist →

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

FieldValue
Enrollment Target 43 participants
Start Date 2011-03-07
Est. Completion 2020-05-09
Phase Phase 1

Sponsor

Novartis Pharmaceuticals

1,375 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.