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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00698464

Collaborator

(none)

Enrollment

Locations

Arm

8.5

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatic Cirrhosis Alcoholism	Drug: Pasireotide	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

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

Study Start Date :

Jul 1, 2008

Actual Primary Completion Date :

Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pasireotide	Drug: Pasireotide Single subcutaneous injection of 600 µg of Pasireotide.

Arm

Intervention/Treatment

Experimental: Pasireotide

Drug: Pasireotide

Single subcutaneous injection of 600 µg of Pasireotide.

Outcome Measures

Primary Outcome Measures

Determination of the pharmacokinetic profile of single dose of pasireotide s.c. injection. [5 days]

Secondary Outcome Measures

Determination of the safety after a single dose of pasireotide s.c. injection [5 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	McGuire Research Institute VAMC	Richmond	Virginia	United States	23249
2	Universite Catholique de Louvain	Brussels		Belgium
3	Novartis Investigative site	Berlin		Germany
4	Novartis Investigative Site	George		South Africa