Pharmacokinetics and Safety of Single Subcutaneous Pasireotide (SOM230) in Subjects With Varying Degrees of Hepatic Function

Alcoholism Clinical Trial

Official title:

A Phase I, Open-label, Multi-center, Single Dose Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Pasireotide (SOM230) in Subjects With Varying Degrees of Hepatic Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00698464
• Other study ID #: CSOM230B2114
• Status: Completed
• Phase: Phase 1
• Start date: July 2008

Study information

• Verified date: November 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion criteria:

Common Inclusion criteria for all subjects:

• Male or female subjects between 18 and 75 years of age, inclusive.

• Vital signs at screening and baseline which are within normal ranges.

• Subjects must have a BMI between 20 kg/m2 and 30 kg/m2.

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:

• Subjects with confirmed cirrhosis by at least one of the following criteria:

• Histologically by prior liver biopsy showing cirrhosis.

• Clinically by physical examination, and/or laboratory data, and/or liver imaging, and/or endoscopic findings.

Exclusion criteria:

Common Exclusion criteria for all subjects:

• Donation or loss of 400 mL or more of blood within eight weeks prior to dosing.

• Subjects with additional active malignant disease within the last five years (with the exception of non-melanoma skin cancers that were not metastatic and have been treated curatively).

• Subjects with abnormal clinical laboratory values (except the clinical laboratory values linked to hepatic dysfunction).

• Any surgical or medical condition that may interfere with the conduct of the study, may jeopardize the subject in case of participation in the study or may significantly alter the absorption, distribution, metabolism or excretion of drugs.

• History of immunocompromise, including a positive HIV test result (ELISA and Western blot). A HIV test will not be required; however, previous medical history will be reviewed

• Female subjects who are pregnant (positive pregnancy test at screening or at baseline) or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control.

Exclusion Criteria for cohort 1:

• Clinical evidence of liver disease or liver injury as indicated by abnormal liver function tests.

• A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result (antibody positive subjects will be allowed if non-viremic).

Exclusion Criteria for cohort 2-4:

• Symptoms or history of encephalopathy (Stage III or worse) within three months prior to dosing.

• Clinical evidence of severe ascites. Exclusion criteria

Common Exclusion criteria for all subjects:

• Donation or loss of 400 mL or more of blood within eight weeks prior to dosing.

• Subjects with additional active malignant disease within the last five years (with the exception of non-melanoma skin cancers that were not metastatic and have been treated curatively).

• Subjects with abnormal clinical laboratory values (except the clinical laboratory values linked to hepatic dysfunction).

• Any surgical or medical condition that may interfere with the conduct of the study, may jeopardize the subject in case of participation in the study or may significantly alter the absorption, distribution, metabolism or excretion of drugs.

• History of immunocompromise, including a positive HIV test result (ELISA and Western blot). A HIV test will not be required; however, previous medical history will be reviewed

• Female subjects who are pregnant (positive pregnancy test at screening or at baseline) or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control.

Exclusion Criteria for cohort 1:

• Clinical evidence of liver disease or liver injury as indicated by abnormal liver function tests.

• A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result (antibody positive subjects will be allowed if non-viremic).

Exclusion Criteria for cohort 2-4:

• Symptoms or history of encephalopathy (Stage III or worse) within three months prior to dosing.

• Clinical evidence of severe ascites.

Related Conditions & MeSH terms

• Alcoholism
• Hepatic Cirrhosis
• Liver Cirrhosis

Intervention

Drug:
• Pasireotide
Single subcutaneous injection of 600 µg of Pasireotide.

Locations

Country	Name	City	State
Belgium	Universite Catholique de Louvain	Brussels
Germany	Novartis Investigative site	Berlin
South Africa	Novartis Investigative Site	George
United States	McGuire Research Institute VAMC	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Belgium,  Germany,  South Africa, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of the pharmacokinetic profile of single dose of pasireotide s.c. injection.		5 days
Secondary	Determination of the safety after a single dose of pasireotide s.c. injection		5 days

External Links

•   Novartis Clinical Trial Results on CSOM230B2114