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

NCT00698464 | Completed Phase 1

• 1 other identifier: CSOM230B2114
• Study Type: interventional
• Target: 34
• Locations: 4 countries
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• Determination of the pharmacokinetic profile of single dose of pasireotide s.c. injection.

  5 days

Secondary Outcomes (1)

• Determination of the safety after a single dose of pasireotide s.c. injection

  5 days

Study Arms (1)

Pasireotide

EXPERIMENTAL

Drug: Pasireotide

Interventions

Pasireotide DRUG

Single subcutaneous injection of 600 µg of Pasireotide.

Pasireotide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (4)

McGuire Research Institute VAMC

Richmond, Virginia, 23249, United States

Location

Universite Catholique de Louvain

Brussels, Belgium

Location

Novartis Investigative site

Berlin, Germany

Location

Novartis Investigative Site

George, South Africa

Location

Related 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. doi: 10.1177/0091270011400072. Epub 2012 Jan 26.

  PMID: 22282526 RESULT

Related Links

• Novartis Clinical Trial Results on CSOM230B2114

MeSH Terms

Conditions

Liver Cirrhosis; Alcoholism

Interventions

pasireotide

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Novartis Pharmaceuticlas

  Novartis Pharmaceuticlas

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2008
• First Posted: June 17, 2008
• Study Start: July 1, 2008
• Primary Completion: April 1, 2009
• Last Updated: December 21, 2020

Record last verified: 2016-11

Locations

US (1); DE (1); BE (1); ZA (1)