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

Phase 1

Completed

• Conditions: Alcoholism; Hepatic Cirrhosis
• Interventions: Drug: Pasireotide

• Registration Number: NCT00698464
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-06-11
• Study First Submitted QC: 2008-06-13
• Study First Posted: 2008-06-17
• Study Start: 2008-07
• Primary Completion: 2009-04
• Status Verified: 2016-11
• Last Update Submitted: 2020-12-17
• Last Update Posted: 2020-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pasireotide	Pasireotide	-

Primary Outcome Measures

Name	Time	Method
Determination of the pharmacokinetic profile of single dose of pasireotide s.c. injection.	5 days

Secondary Outcome Measures

Name	Time	Method
Determination of the safety after a single dose of pasireotide s.c. injection	5 days

Trial Locations

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