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

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ClinicalTrials.gov Identifier: NCT01860326
Recruitment Status : Completed
First Posted : May 22, 2013
Last Update Posted : April 28, 2016
Sponsor:
Information provided by (Responsible Party):
Debiopharm International SA

Brief 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.

Condition or disease Intervention/treatment Phase
Hepatic Insufficiency Drug: Alisporivir Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official 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
Study Start Date : March 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Arm Intervention/treatment
Experimental: Alisporivir
Single 200 mg oral dose
Drug: Alisporivir
Capsules supplied as open labeled bulk medication in 10-unit blister packages
Other Name: DEB025




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01860326


Locations
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United States, Florida
University of Miami
Miami, Florida, United States, 33136
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
Sponsors and Collaborators
Debiopharm International SA
Investigators
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Study Director: Study Director Novartis Institutes for BioMedical Research

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Responsible Party: Debiopharm International SA
ClinicalTrials.gov Identifier: NCT01860326     History of Changes
Other Study ID Numbers: CDEB025A2114
First Posted: May 22, 2013    Key Record Dates
Last Update Posted: April 28, 2016
Last Verified: April 2016

Keywords provided by Debiopharm International SA:
hepatic impairment
mild and moderate hepatic impairment
Alisporivir

Additional relevant MeSH terms:
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Liver Diseases
Hepatic Insufficiency
Liver Failure
Digestive System Diseases
Cyclosporine
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Calcineurin Inhibitors