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

• Register: ClinicalTrials.gov
• Last refreshed on: 22 April 2013
• Main ID: NCT01429337
• Date of registration: 12/07/2011
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Pharmacokinetics and Safety of Midostaurin in Subjects With Impaired Hepatic Function and Subjects With Normal Hepatic Function
• Scientific title: An Open-label, Multiple Dose, Parallel Group, Phase I Study to Assess the Pharmacokinetics and Safety of Midostaurin in Subjects With Impaired Hepatic Function and Subjects With Normal Hepatic Function
• Date of first enrolment: March 2011
• Target sample size: 42
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01429337
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Countries of recruitment

Belgium, Bulgaria, Germany, Romania, South Africa

Contacts

• Name: Novartis Pharmaceuticals

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion Criteria:

• Subjects must be able to communicate well with the Investigator and comply with the
requirements of the study.

Exclusion Criteria:

- Significant neurologic or psychiatric disorder which could compromise participation
in the study.

- Subjects with known ongoing alcohol and/or drug abuse within 1 month prior to dosing
or evidence of such abuse.

- Use of tobacco or products containing nicotine within 7 days prior to dosing or
during the study.

- Consumption of alcohol within 3 days prior to dosing or during the study.

- Women of childbearing potential unless they are using a highly effective
contraception method the length of the study and for at least for at least 3 months
after the last exposure to midostaurin. Highly effective methods include: Total
abstinence, female sterilization or male partner sterilization. Or use a combination
of (a+b): a) Placement of an intrauterine device or intrauterine system , b)barrier
method of contraception

- Sexually active males unless they use condom during intercourse while taking
midostaurin and for at least 3 months after the last exposure to drug. A condom is
required to be used also by vasectomized men.

Other protocol-defined inclusion/exclusion criteria may apply



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Hepatic Impairment

Intervention(s)

Drug: Midostaurin

Primary Outcome(s)

composite of pharmacokinetics (PK) of midostaurin in subjects with mild, moderate, and severely impaired hepatic function relative to healthy controls by analyzing plasma samples [Time Frame: at different timepoints from Day 1 to Day 11]

Secondary Outcome(s)

potential CYP3A4 induction by midostaurin in the hepatic impaired population by assessing endogenous biomarkers (6beta-hydroxycortisol to cortisol ratio) [Time Frame: At different timepoints from Day 3 to Day 11]

protein binding by assessing the level of a1-acid glycoprotein (AAG) in plasma samples [Time Frame: At baseline (day -1) for the protein binding and Day 1 + Day 7 for the free fraction]

the relationship between pharmacokinetics and hepatic function parameters by assessing total bilirubin, prothrombin time and albumin [Time Frame: At different timepoints from Day 1 to Day 11]

the safety and tolerability of midostaurin in subjects with hepatic impairment by assessing the AEs, SAEs, including abnormalities of laboratory parameters [Time Frame: During the study and until 28 days follow-up period]

Secondary ID(s)

2010-020694-16

CPKC412A2116

Source(s) of Monetary Support

Please refer to primary and secondary sponsors