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Pharmacokinetics and Safety of Single Subcutaneous Pasireotide (SOM230) in Subjects With Varying Degrees of Hepatic Function | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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

NCT00698464•Novartis Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.
+9 more criteria

Locations (4)

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

Key Dates

Start Date

July 1, 2008

Primary Completion Date

April 1, 2009

Last Updated

December 21, 2020

Enrollment

ACTUAL participants

Conditions

Hepatic CirrhosisAlcoholism

Interventions

Pasireotide

DRUG

SMART-r: Substance Monitoring and Active Relapse Tracking Repository

NCT06676059

AlcoholismSubstance-Related Disorders

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RECRUITINGPHASE2

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NCT06939088

Alcohol Use DisorderAlcohol Abuse/Dependence+6 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 21, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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