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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pasireotide | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pasireotide | Drug | Single subcutaneous injection of 600 µg of Pasireotide. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determination of the pharmacokinetic profile of single dose of pasireotide s.c. injection. | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of the safety after a single dose of pasireotide s.c. injection | 5 days |
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Inclusion criteria:
Common Inclusion criteria for all subjects:
Inclusion Criteria for cohort 1:
• Generally healthy subjects as determined by past medical history, physical examination, vital signs, electrocardiogram and standard laboratory tests at screening.
Inclusion Criteria for cohort 2-4:
Exclusion criteria:
Common Exclusion criteria for all subjects:
Exclusion Criteria for cohort 1:
Exclusion Criteria for cohort 2-4:
Common Exclusion criteria for all subjects:
Exclusion Criteria for cohort 1:
Exclusion Criteria for cohort 2-4:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticlas | Novartis Pharmaceuticlas | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McGuire Research Institute VAMC | Richmond | Virginia | 23249 | United States | ||
| Universite Catholique de Louvain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22282526 | Result | Horsmans Y, Hu K, Ruffin M, Wang Y, Song D, Bouillaud E, Wang Y, Mazur D, Botha FP, Heuman DM. Effect of hepatic impairment on the pharmacokinetics of pasireotide (SOM230): results from a multicenter phase I study. J Clin Pharmacol. 2012 Apr;52(4):552-8. doi: 10.1177/0091270011400072. Epub 2012 Jan 26. |
| Label | URL |
|---|---|
| Novartis Clinical Trial Results on CSOM230B2114 | View source |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C517782 | pasireotide |
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| Brussels |
| Belgium |
| Novartis Investigative site | Berlin | Germany |
| Novartis Investigative Site | George | South Africa |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |