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

NCT ID: NCT00698464

Last Updated: 2020-12-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31

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.

Conditions

Hepatic Cirrhosis; Alcoholism

Keywords

Pasireotide; PK profile,; Single dose; Pasireotide subcutaneous injection; Safety; Mild hepatic impaired patients; Moderate hepatic impaired patients; Severe hepatic impaired patients

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Pasireotide

Group Type: EXPERIMENTAL

Pasireotide

Intervention Type: DRUG

Single subcutaneous injection of 600 µg of Pasireotide.

Interventions

Pasireotide

Single subcutaneous injection of 600 µg of Pasireotide.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

• Generally healthy subjects as determined by past medical history, physical examination, vital signs, electrocardiogram and standard laboratory tests at screening.

• 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

• 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.

• 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).

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

• 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.

• 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).

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticlas

Role: STUDY_DIRECTOR

Novartis Pharmaceuticlas

Locations

McGuire Research Institute VAMC

Richmond, Virginia, United States

Universite Catholique de Louvain

Brussels, , Belgium

Novartis Investigative site

Berlin, , Germany

Novartis Investigative Site

George, , South Africa

Countries

United States; Belgium; Germany; South Africa

References

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.

Reference Type: RESULT

PMID: 22282526 (View on PubMed)

Related Links

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=2920

Novartis Clinical Trial Results on CSOM230B2114

Other Identifiers

CSOM230B2114

Identifier Type: -

Identifier Source: org_study_id