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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00698464

Enrollment

Registered

2008-06-17

Start date

2008-07-31

Completion date

Unknown

Last updated

2020-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcoholism, Hepatic Cirrhosis

Keywords

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

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.

Interventions

DRUGPasireotide

Single subcutaneous injection of 600 µg of Pasireotide.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

Common Inclusion criteria for all subjects: * 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. Inclusion Criteria for cohort 1: • Generally healthy subjects as determined by past medical history, physical examination, vital signs, electrocardiogram and standard laboratory tests at screening. Inclusion Criteria for cohort 2-4: * 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

Common

Design outcomes

Primary

Measure	Time frame
Determination of the pharmacokinetic profile of single dose of pasireotide s.c. injection.	5 days

Secondary

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

Countries

Belgium, Germany, South Africa, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026