PK and Safety of Midostaurin in Subjects With Impaired Hepatic Function and Subjects With Normal Hepatic Function
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 12/15/2018 |
| Start Date: | March 7, 2011 |
| End Date: | August 14, 2019 |
| Contact: | Novartis Pharmaceuticals |
| Email: | novartis.email@novartis.com |
| Phone: | 1-888-669-6682 |
An Open-label, 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
The purpose of this international study is 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.
impaired hepatic function compared to a normal hepatic function (Child-Pugh classification)
on the pharmacokinetics and safety of midostaurin.
Midostaurin is developed for the treatment of patients with hematological and
nonhematological malignancies. However, disease complications and various co-medications
render a hepatic impairment study in the targeted patient population difficult.
Metabolism and elimination of midostaurin is predominantly occurring in the liver. Patients
with impaired hepatic function may have a higher risk to have a decreased elimination or
metabolism of midostaurin which may lead to increased systemic exposure or toxicity, hence
understanding the impact of an impaired hepatic function on midostaurin PK is important.
Cumulative safety data from over 900 subjects exposed to midostaurin showed that the drug is
well tolerated in patients and in healthy subjects, thus, it is appropriate and justifiable
to study midostaurin in subjects with varying degrees of hepatic impairment.
nonhematological malignancies. However, disease complications and various co-medications
render a hepatic impairment study in the targeted patient population difficult.
Metabolism and elimination of midostaurin is predominantly occurring in the liver. Patients
with impaired hepatic function may have a higher risk to have a decreased elimination or
metabolism of midostaurin which may lead to increased systemic exposure or toxicity, hence
understanding the impact of an impaired hepatic function on midostaurin PK is important.
Cumulative safety data from over 900 subjects exposed to midostaurin showed that the drug is
well tolerated in patients and in healthy subjects, thus, it is appropriate and justifiable
to study midostaurin in subjects with varying degrees of hepatic impairment.
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.
- Subjects with cotinine levels greater than 500ng/mL are considered as smokers and will
not be enrolled.
- Consumption of alcohol within 3 days prior to dosing or during the study.
- 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 as well during intercourse with a male
partner in order to prevent delivery of the drug via semen.
Other protocol-defined inclusion/exclusion criteria may apply
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