Skip to main content
OpenTrials
Completed

NCT Number: NCT01860326

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatic Insufficiency Digestive System Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Liver Diseases Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Miami, Miami, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Alisporivir

Drug

Capsules supplied as open labeled bulk medication in 10-unit blister packages

Other names: DEB025

Primary outcomes

  1. Maximum Concentration (Cmax) of alisporivir

    Time frame: 0.5 h (± 5 min), 1 h (± 10 min), 2 h (± 10 min), 4 h (± 30 min), 6 h (± 30 min), 8 h (± 30 min), 12 h (± 30 min), 24 h (± 60 min), 48 h (± 60 min), 72 h (± 60 min), 96 h (± 60 min), 120 h (± 60 min), 144 h (± 60 min), and 168 h (± 60 min) post-dose

  2. Area under the time-concentration curve (AUC) for alisporivir

    Time frame: 0.5 h (± 5 min), 1 h (± 10 min), 2 h (± 10 min), 4 h (± 30 min), 6 h (± 30 min), 8 h (± 30 min), 12 h (± 30 min), 24 h (± 60 min), 48 h (± 60 min), 72 h (± 60 min), 96 h (± 60 min), 120 h (± 60 min), 144 h (± 60 min), and 168 h (± 60 min) post-dose

    Categories: AUC up to the last measurable concentration (AUClast) and AUC from time 0 to the last time point measured (AUC0-t)

Secondary outcomes

  1. Time to maximum concentration (Tmax) of alisporivir

    Time frame: 0.5 h (± 5 min), 1 h (± 10 min), 2 h (± 10 min), 4 h (± 30 min), 6 h (± 30 min), 8 h (± 30 min), 12 h (± 30 min), 24 h (± 60 min), 48 h (± 60 min), 72 h (± 60 min), 96 h (± 60 min), 120 h (± 60 min), 144 h (± 60 min), and 168 h (± 60 min) post-dose

  2. Half-Life (T1/2) of alisporivir

    Time frame: 0.5 h (± 5 min), 1 h (± 10 min), 2 h (± 10 min), 4 h (± 30 min), 6 h (± 30 min), 8 h (± 30 min), 12 h (± 30 min), 24 h (± 60 min), 48 h (± 60 min), 72 h (± 60 min), 96 h (± 60 min), 120 h (± 60 min), 144 h (± 60 min), and 168 h (± 60 min) post-dose

  3. Apparent total body clearance from plasma (CL/F) of alisporivir

    Time frame: 0.5 h (± 5 min), 1 h (± 10 min), 2 h (± 10 min), 4 h (± 30 min), 6 h (± 30 min), 8 h (± 30 min), 12 h (± 30 min), 24 h (± 60 min), 48 h (± 60 min), 72 h (± 60 min), 96 h (± 60 min), 120 h (± 60 min), 144 h (± 60 min), and 168 h (± 60 min) post-dose

  4. Apparent volume of distribution (Vz/F) of alisporivir

    Time frame: 0.5 h (± 5 min), 1 h (± 10 min), 2 h (± 10 min), 4 h (± 30 min), 6 h (± 30 min), 8 h (± 30 min), 12 h (± 30 min), 24 h (± 60 min), 48 h (± 60 min), 72 h (± 60 min), 96 h (± 60 min), 120 h (± 60 min), 144 h (± 60 min), and 168 h (± 60 min) post-dose

Sponsors and collaborators

Lead sponsor

Debiopharm International SA

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 22, 2013
Registry last updated
Apr 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.