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

PHASE1CompletedINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

March 7, 2011

Primary Completion Date

April 13, 2020

Study Completion Date

May 9, 2020

Conditions
Hepatic Impairment
Interventions
DRUG

Midostaurin

Midostaurin 25 mg soft gelatin capsules (2 capsules). The midostaurin capsules will be administered orally with 240 mL of non-carbonated water in the morning (between 8-10 AM), and in the evening (after a 12 hour break) from Day 1 to Day 6. On Day 7, midostaurin will be administered in the morning only (between 8-10 AM).

DRUG

Midostaurin

Midostaurin 25 mg soft gelatin capsules (2 capsules). The midostaurin capsules will be administered orally with 240 mL of non-carbonated water in the morning (between 8-10 AM) on Day 1 only.

Trial Locations (7)

1200

Novartis Investigative Site, Brussels

1618

Novartis Investigative Site, Sofia

14050

Novartis Investigative Site, Berlin

60590

Novartis Investigative Site, Frankfurt

78215

American Research Corporation Inc, San Antonio

400006

Novartis Investigative Site, Cluj-Napoca

LT 50161

Novartis Investigative Site, Kaunas

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY