Pharmacokinetics and Safety of Single Subcutaneous Pasireotide (SOM230) in Subjects With Varying Degrees of Hepatic Function
- Registration Number
- NCT00698464
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
The purpose of this study is to evaluate the effect of varying degrees of hepatic function (Child-Pugh classification) on the pharmacokinetics and safety of pasireotide s.c. in subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pasireotide Pasireotide -
- Primary Outcome Measures
Name Time Method Determination of the pharmacokinetic profile of single dose of pasireotide s.c. injection. 5 days
- Secondary Outcome Measures
Name Time Method Determination of the safety after a single dose of pasireotide s.c. injection 5 days
Trial Locations
- Locations (4)
Novartis Investigative site
🇩🇪Berlin, Germany
Novartis Investigative Site
🇿🇦George, South Africa
Universite Catholique de Louvain
🇧🇪Brussels, Belgium
McGuire Research Institute VAMC
🇺🇸Richmond, Virginia, United States