Loading clinical trials...

Evaluate the Pharmacokinetics, Safety, and Tolerability of Alisporivir in Subjects With Hepatic Impairment Compared to Healthy Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Evaluate the Pharmacokinetics, Safety, and Tolerability of Alisporivir in Subjects With Hepatic Impairment Compared to Healthy Subjects

An Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Single Oral Doses of DEB025 in Subjects With Mild and Moderate Hepatic Impairment Compared to Matched Healthy Subjects With Normal Liver Function

NCT01860326•Debiopharm International SA

View on ClinicalTrials.gov

Summary

This is an open-label study to evaluate the pharmacokinetics, safety and tolerability of single oral doses of Alisporivir in subjects with mild and moderate hepatic impairment compared to matched healthy subjects with normal liver function.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Male or female, 18 to 70 years of age, in good health
•Stable Child-Turcotte-Pugh score of at least 5
•Body weight of at least 50 kg and a BMI of 18.0 to 36.0 kg/m2

Exclusion Criteria

•Use of other investigational drugs
•Women of child-bearing potential

Locations (2)

University of Miami

Miami, Florida, United States

Orlando Clinical Research Center

Orlando, Florida, United States

Key Dates

Start Date

March 1, 2011

Primary Completion Date

September 1, 2011

Completion Date

September 1, 2011

Last Updated

April 28, 2016

Enrollment

ACTUAL participants

Conditions

Hepatic Insufficiency

Interventions

Alisporivir

DRUG

Diagnosis of Lymphohistiocytic Hemophagocytosis in Intensive Care

NCT07343037

Hepatic InsufficiencyCirrhosis, Liver

View study

TERMINATEDPHASE1

A Study to Evaluate CC-486/Onureg in Participants With Moderate or Severe Hepatic Impairment Compared With Normal Hepatic Function in Participants With Myeloid Malignancies

NCT05209295

Hepatic InsufficiencyNeoplasms

View study

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: April 28, 2016Data 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.

View ClinicalTrials.gov Terms and Conditions

Evaluate the Pharmacokinetics, Safety, and Tolerability of Alisporivir in Subjects With Hepatic Impairment Compared to Healthy Subjects

Inclusion Criteria

Exclusion Criteria

Diagnosis of Lymphohistiocytic Hemophagocytosis in Intensive Care

A Study to Evaluate CC-486/Onureg in Participants With Moderate or Severe Hepatic Impairment Compared With Normal Hepatic Function in Participants With Myeloid Malignancies

A Study of Imlunestrant (LY3484356) in Female Participants With Impaired Liver Function

A Study of Olomorasib (LY3537982) in Participants With Hepatic Impairment and Healthy Participants

Hepato Biliary Scintigraphy to Assess the Risk of Postoperative Liver Failure Hepatectomies

Ulonivirine (MK-8507) in Participants With Mild or Moderate Hepatic Impairment (MK-8507-014)