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

NCT00698464 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2020-12-21

No results posted yet for this study

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

Interventions

DRUG

Pasireotide

Single subcutaneous injection of 600 µg of Pasireotide.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticlas · Novartis Pharmaceuticlas

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2009-04-30

Countries

  • United States
  • Belgium
  • Germany
  • South Africa

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00698464 on ClinicalTrials.gov