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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00698464
First received: June 11, 2008
Last updated: May 29, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Hepatic Cirrhosis
Alcoholism
Drug: Pasireotide
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Determination of the pharmacokinetic profile of single dose of pasireotide s.c. injection. [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determination of the safety after a single dose of pasireotide s.c. injection [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]

Enrollment: 34
Study Start Date: July 2008
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pasireotide Drug: Pasireotide
Single subcutaneous injection of 600 µg of Pasireotide.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00698464

Locations
United States, Virginia
McGuire Research Institute VAMC
Richmond, Virginia, United States, 23249
Belgium
Universite Catholique de Louvain
Brussels, Belgium
Germany
Novartis Investigative site
Berlin, Germany
South Africa
Novartis Investigative Site
George, South Africa
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticlas Novartis Pharmaceuticlas
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00698464     History of Changes
Other Study ID Numbers: CSOM230B2114
Study First Received: June 11, 2008
Last Updated: May 29, 2012
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Belgium: Federal Agency for Medicinal Products and Health Products
South Africa: Medicines Control Council

Keywords provided by Novartis:
Pasireotide
PK profile,
Single dose
Pasireotide subcutaneous injection
Safety
Mild hepatic impaired patients
Moderate hepatic impaired patients
Severe hepatic impaired patients

Additional relevant MeSH terms:
Alcoholism
Liver Cirrhosis
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on October 19, 2014