PK and Safety of Midostaurin in Subjects With Impaired Hepatic Function and Subjects With Normal Hepatic Function

Completed · Phase 1

Conditions studied: Hepatic Impairment

In brief

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.

Key facts

Study ID

NCT01429337

Run by

Novartis Pharmaceuticals

People needed

43

Starts

2011-03-07

Expected to finish

2020-05-09

Last updated by the study team

2021-05-12

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

Where it is running

• American Research Corporation Inc — San Antonio, Texas, United States
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Sofia, Bulgaria
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Frankfurt, Germany
• Novartis Investigative Site — Kaunas, LTU, Lithuania
• Novartis Investigative Site — Cluj-Napoca, Napoca, Romania

Full record on ClinicalTrials.gov

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